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Safer opioid supply program in Canada helps those who face overdose risks
An analysis indicates that the program is associated with a reduction in emergency department visits, hospitalizations, and overall health care costs. In addition, there were no opioid-related deaths among participants who were at high risk of overdose.
“Not only did hospital engagements decline immediately after starting SOS programs, but also the risk of overdose did not change, and there were no opioid-related deaths in the 1-year follow-up,” study author Tara Gomes, PhD, an assistant professor of health policy, management, and evaluation at the University of Toronto and a scientist at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, said in an interview.
Dr. Gomes is the lead principal investigator of the Ontario Drug Policy Research Network, a collaboration between researchers and drug policy decision-makers in the province.
“These changes were not seen in a group of similar individuals who lived in the same city – so were exposed to the same illicit drug supply – but who were not part of this program, helping to reinforce that these changes are specific to SOS participation,” she said.
The study was published in the Canadian Medical Association Journal.
Hospital admissions declined
More than 29,000 opioid-related toxicity deaths occurred in Canada between 2016 and 2021, often as a result of high levels of fentanyl in the drug supply, according to the investigators. In response, SOS programs have been launched in several provinces, including the first formal SOS program at the London (Ont.) InterCommunity Health Centre. As part of the program, clients are prescribed pharmaceutical opioids as an alternative to the fentanyl-adulterated drug supply and are given health and social supports.
Dr. Gomes and colleagues conducted an interrupted time series analysis of residents in London, Ont., who had received a diagnosis of opioid use disorder and had had a health care encounter related to the diagnosis between January 2016 and March 2019. They followed 82 participants who entered the SOS program, as well as a comparison group of 303 people who were matched on the basis of demographic and clinical characteristics but who did not participate in the program.
The research team focused on the population’s numbers of emergency department visits, hospital admissions, infection rates, and health care costs. They used autoregressive integrated moving average models to evaluate the effect of starting the SOS program and to compare the population’s outcome rates in the year before and after entering the program.
For participants who entered the program, the rate of emergency department visits declined by about 14 visits per 100 people. In addition, hospital admissions declined by about 5 admissions per 100 people. Health care costs that weren’t related to primary care or outpatient medications declined by about $922 per person. The rate of hospital admission for infections remained about the same; the investigators observed a decline of about 1.6 infections per 100 people.
In the year after entry into the program, emergency department visits, hospital admissions, infection-related admissions, and total health care costs declined significantly among SOS clients, compared with the year before.
Conversely, there were no significant changes in any of the measured outcomes among the 303 people who didn’t participate in the program.
Medication costs increased
DR. Gomes and colleagues noted that the findings provide preliminary evidence that SOS programs can play a role in the harm-reduction options available to those who are at high risk of drug poisoning and overdose. At the same time, many questions remain.
For instance, although total health care costs declined among those enrolled in the program, the medication-related costs increased. About 34% of participants had HIV, 69.5% had hepatitis C virus infection, and 28% had infectious complications in the year before entering the program. This finding may indicate that the participants had serious medical complications resulting from their drug use and were able to seek health care services.
“We interpret that to be a positive finding, because of the very high prevalence of HIV and hepatitis C in the SOS clients. Treatments for HIV and hepatitis C are lifesaving but expensive,” said Dr. Gomes. “Therefore, these higher medication costs are likely reflective of improved access to treatments for these infections, which can greatly improve people’s health and quality of life but also save the health care system money over the longer term.”
DR. Gomes and colleagues are now beginning to evaluate other SOS programs across Ontario. They hope to better understand the various approaches that are available and determine which models can best support people who face high risks because of drug use.
A limited solution?
Commenting on the study, Andrew Ivsins, PhD, a postdoctoral fellow in social medicine at the University of British Columbia in Vancouver and a research scientist at the British Columbia Centre on Substance Abuse, said, “This is an important study and one of the first to show how safe supply can help by building connections to the health care system that didn’t exist previously.”
Dr. Ivsins, who wasn’t involved with this study, has researched safe supply programs around Vancouver. He and colleagues found that among participants in these programs, the use of illicit street-purchased drugs decreased, which led to improved health and wellness.
“Safe supply is fundamentally, at the most basic level, a response to the highly toxic drug supply and out-of-control poisoning crisis in North America,” he said. “It’s a contentious issue, but it makes so much sense that, if what’s killing people is highly toxic drugs, we need to find a way to provide an option that doesn’t kill them.”
“Up to now, safer supply has mostly been used to reduce harms, including mortality and morbidity, in persons using illicit opioids. But if we really want to lower the risk linked to heavy contamination of the unregulated drug supply, safer supply programs will have to be extended to all substances potentially sold illegally,” Marie-Eve Goyer, MD, an assistant professor of family medicine at the University of Montreal, said in an interview.
Dr. Goyer, who wasn’t involved with this study, has conducted research about substance replacement therapy in Quebec. She found that many provinces are now reporting on new potent designer benzodiazepines that are being used or that are contaminating fentanyl, which calls for a broader approach to address the drug overdose crisis.
“Let’s realize that safer supply prescription is a very medicalized (and limited) solution to an epidemic that is made of stigma, criminalization, and repressive public policies,” she said. “Without true changes in the law, we will continue to see our people dying every day.”
The study was funded by grants from the Ontario Ministry of Health and the Canadian Institutes of Health Research. Dr. Gomes has received grants to support the research of both groups, and other authors have received support or fees related to the London InterCommunity Health Centre. Dr. Ivsins and Dr. Goyer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An analysis indicates that the program is associated with a reduction in emergency department visits, hospitalizations, and overall health care costs. In addition, there were no opioid-related deaths among participants who were at high risk of overdose.
“Not only did hospital engagements decline immediately after starting SOS programs, but also the risk of overdose did not change, and there were no opioid-related deaths in the 1-year follow-up,” study author Tara Gomes, PhD, an assistant professor of health policy, management, and evaluation at the University of Toronto and a scientist at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, said in an interview.
Dr. Gomes is the lead principal investigator of the Ontario Drug Policy Research Network, a collaboration between researchers and drug policy decision-makers in the province.
“These changes were not seen in a group of similar individuals who lived in the same city – so were exposed to the same illicit drug supply – but who were not part of this program, helping to reinforce that these changes are specific to SOS participation,” she said.
The study was published in the Canadian Medical Association Journal.
Hospital admissions declined
More than 29,000 opioid-related toxicity deaths occurred in Canada between 2016 and 2021, often as a result of high levels of fentanyl in the drug supply, according to the investigators. In response, SOS programs have been launched in several provinces, including the first formal SOS program at the London (Ont.) InterCommunity Health Centre. As part of the program, clients are prescribed pharmaceutical opioids as an alternative to the fentanyl-adulterated drug supply and are given health and social supports.
Dr. Gomes and colleagues conducted an interrupted time series analysis of residents in London, Ont., who had received a diagnosis of opioid use disorder and had had a health care encounter related to the diagnosis between January 2016 and March 2019. They followed 82 participants who entered the SOS program, as well as a comparison group of 303 people who were matched on the basis of demographic and clinical characteristics but who did not participate in the program.
The research team focused on the population’s numbers of emergency department visits, hospital admissions, infection rates, and health care costs. They used autoregressive integrated moving average models to evaluate the effect of starting the SOS program and to compare the population’s outcome rates in the year before and after entering the program.
For participants who entered the program, the rate of emergency department visits declined by about 14 visits per 100 people. In addition, hospital admissions declined by about 5 admissions per 100 people. Health care costs that weren’t related to primary care or outpatient medications declined by about $922 per person. The rate of hospital admission for infections remained about the same; the investigators observed a decline of about 1.6 infections per 100 people.
In the year after entry into the program, emergency department visits, hospital admissions, infection-related admissions, and total health care costs declined significantly among SOS clients, compared with the year before.
Conversely, there were no significant changes in any of the measured outcomes among the 303 people who didn’t participate in the program.
Medication costs increased
DR. Gomes and colleagues noted that the findings provide preliminary evidence that SOS programs can play a role in the harm-reduction options available to those who are at high risk of drug poisoning and overdose. At the same time, many questions remain.
For instance, although total health care costs declined among those enrolled in the program, the medication-related costs increased. About 34% of participants had HIV, 69.5% had hepatitis C virus infection, and 28% had infectious complications in the year before entering the program. This finding may indicate that the participants had serious medical complications resulting from their drug use and were able to seek health care services.
“We interpret that to be a positive finding, because of the very high prevalence of HIV and hepatitis C in the SOS clients. Treatments for HIV and hepatitis C are lifesaving but expensive,” said Dr. Gomes. “Therefore, these higher medication costs are likely reflective of improved access to treatments for these infections, which can greatly improve people’s health and quality of life but also save the health care system money over the longer term.”
DR. Gomes and colleagues are now beginning to evaluate other SOS programs across Ontario. They hope to better understand the various approaches that are available and determine which models can best support people who face high risks because of drug use.
A limited solution?
Commenting on the study, Andrew Ivsins, PhD, a postdoctoral fellow in social medicine at the University of British Columbia in Vancouver and a research scientist at the British Columbia Centre on Substance Abuse, said, “This is an important study and one of the first to show how safe supply can help by building connections to the health care system that didn’t exist previously.”
Dr. Ivsins, who wasn’t involved with this study, has researched safe supply programs around Vancouver. He and colleagues found that among participants in these programs, the use of illicit street-purchased drugs decreased, which led to improved health and wellness.
“Safe supply is fundamentally, at the most basic level, a response to the highly toxic drug supply and out-of-control poisoning crisis in North America,” he said. “It’s a contentious issue, but it makes so much sense that, if what’s killing people is highly toxic drugs, we need to find a way to provide an option that doesn’t kill them.”
“Up to now, safer supply has mostly been used to reduce harms, including mortality and morbidity, in persons using illicit opioids. But if we really want to lower the risk linked to heavy contamination of the unregulated drug supply, safer supply programs will have to be extended to all substances potentially sold illegally,” Marie-Eve Goyer, MD, an assistant professor of family medicine at the University of Montreal, said in an interview.
Dr. Goyer, who wasn’t involved with this study, has conducted research about substance replacement therapy in Quebec. She found that many provinces are now reporting on new potent designer benzodiazepines that are being used or that are contaminating fentanyl, which calls for a broader approach to address the drug overdose crisis.
“Let’s realize that safer supply prescription is a very medicalized (and limited) solution to an epidemic that is made of stigma, criminalization, and repressive public policies,” she said. “Without true changes in the law, we will continue to see our people dying every day.”
The study was funded by grants from the Ontario Ministry of Health and the Canadian Institutes of Health Research. Dr. Gomes has received grants to support the research of both groups, and other authors have received support or fees related to the London InterCommunity Health Centre. Dr. Ivsins and Dr. Goyer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An analysis indicates that the program is associated with a reduction in emergency department visits, hospitalizations, and overall health care costs. In addition, there were no opioid-related deaths among participants who were at high risk of overdose.
“Not only did hospital engagements decline immediately after starting SOS programs, but also the risk of overdose did not change, and there were no opioid-related deaths in the 1-year follow-up,” study author Tara Gomes, PhD, an assistant professor of health policy, management, and evaluation at the University of Toronto and a scientist at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, said in an interview.
Dr. Gomes is the lead principal investigator of the Ontario Drug Policy Research Network, a collaboration between researchers and drug policy decision-makers in the province.
“These changes were not seen in a group of similar individuals who lived in the same city – so were exposed to the same illicit drug supply – but who were not part of this program, helping to reinforce that these changes are specific to SOS participation,” she said.
The study was published in the Canadian Medical Association Journal.
Hospital admissions declined
More than 29,000 opioid-related toxicity deaths occurred in Canada between 2016 and 2021, often as a result of high levels of fentanyl in the drug supply, according to the investigators. In response, SOS programs have been launched in several provinces, including the first formal SOS program at the London (Ont.) InterCommunity Health Centre. As part of the program, clients are prescribed pharmaceutical opioids as an alternative to the fentanyl-adulterated drug supply and are given health and social supports.
Dr. Gomes and colleagues conducted an interrupted time series analysis of residents in London, Ont., who had received a diagnosis of opioid use disorder and had had a health care encounter related to the diagnosis between January 2016 and March 2019. They followed 82 participants who entered the SOS program, as well as a comparison group of 303 people who were matched on the basis of demographic and clinical characteristics but who did not participate in the program.
The research team focused on the population’s numbers of emergency department visits, hospital admissions, infection rates, and health care costs. They used autoregressive integrated moving average models to evaluate the effect of starting the SOS program and to compare the population’s outcome rates in the year before and after entering the program.
For participants who entered the program, the rate of emergency department visits declined by about 14 visits per 100 people. In addition, hospital admissions declined by about 5 admissions per 100 people. Health care costs that weren’t related to primary care or outpatient medications declined by about $922 per person. The rate of hospital admission for infections remained about the same; the investigators observed a decline of about 1.6 infections per 100 people.
In the year after entry into the program, emergency department visits, hospital admissions, infection-related admissions, and total health care costs declined significantly among SOS clients, compared with the year before.
Conversely, there were no significant changes in any of the measured outcomes among the 303 people who didn’t participate in the program.
Medication costs increased
DR. Gomes and colleagues noted that the findings provide preliminary evidence that SOS programs can play a role in the harm-reduction options available to those who are at high risk of drug poisoning and overdose. At the same time, many questions remain.
For instance, although total health care costs declined among those enrolled in the program, the medication-related costs increased. About 34% of participants had HIV, 69.5% had hepatitis C virus infection, and 28% had infectious complications in the year before entering the program. This finding may indicate that the participants had serious medical complications resulting from their drug use and were able to seek health care services.
“We interpret that to be a positive finding, because of the very high prevalence of HIV and hepatitis C in the SOS clients. Treatments for HIV and hepatitis C are lifesaving but expensive,” said Dr. Gomes. “Therefore, these higher medication costs are likely reflective of improved access to treatments for these infections, which can greatly improve people’s health and quality of life but also save the health care system money over the longer term.”
DR. Gomes and colleagues are now beginning to evaluate other SOS programs across Ontario. They hope to better understand the various approaches that are available and determine which models can best support people who face high risks because of drug use.
A limited solution?
Commenting on the study, Andrew Ivsins, PhD, a postdoctoral fellow in social medicine at the University of British Columbia in Vancouver and a research scientist at the British Columbia Centre on Substance Abuse, said, “This is an important study and one of the first to show how safe supply can help by building connections to the health care system that didn’t exist previously.”
Dr. Ivsins, who wasn’t involved with this study, has researched safe supply programs around Vancouver. He and colleagues found that among participants in these programs, the use of illicit street-purchased drugs decreased, which led to improved health and wellness.
“Safe supply is fundamentally, at the most basic level, a response to the highly toxic drug supply and out-of-control poisoning crisis in North America,” he said. “It’s a contentious issue, but it makes so much sense that, if what’s killing people is highly toxic drugs, we need to find a way to provide an option that doesn’t kill them.”
“Up to now, safer supply has mostly been used to reduce harms, including mortality and morbidity, in persons using illicit opioids. But if we really want to lower the risk linked to heavy contamination of the unregulated drug supply, safer supply programs will have to be extended to all substances potentially sold illegally,” Marie-Eve Goyer, MD, an assistant professor of family medicine at the University of Montreal, said in an interview.
Dr. Goyer, who wasn’t involved with this study, has conducted research about substance replacement therapy in Quebec. She found that many provinces are now reporting on new potent designer benzodiazepines that are being used or that are contaminating fentanyl, which calls for a broader approach to address the drug overdose crisis.
“Let’s realize that safer supply prescription is a very medicalized (and limited) solution to an epidemic that is made of stigma, criminalization, and repressive public policies,” she said. “Without true changes in the law, we will continue to see our people dying every day.”
The study was funded by grants from the Ontario Ministry of Health and the Canadian Institutes of Health Research. Dr. Gomes has received grants to support the research of both groups, and other authors have received support or fees related to the London InterCommunity Health Centre. Dr. Ivsins and Dr. Goyer have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANADIAN MEDICAL ASSOCIATION JOURNAL
Could a vaccine (and more) fix the fentanyl crisis?
This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.
Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.
Welcome, Dr Christo.
Paul J. Christo, MD, MBA: Thanks so much for having me.
Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. , based on recent data from the CDC.
Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.
Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.
What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.
Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.
Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).
There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.
Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
Addressing the synthetic opioid crisis
Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.
In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?
Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.
Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.
Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?
Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.
Fentanyl test strips
Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.
Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.
Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.
The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.
Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?
Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.
Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?
Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.
It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
Vaccines to combat the synthetic opioid crisis
Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?
Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.
Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.
Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?
Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.
Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.
One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.
Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.
Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?
Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.
Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.
Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.
A version of this article first appeared on Medscape.com.
This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.
Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.
Welcome, Dr Christo.
Paul J. Christo, MD, MBA: Thanks so much for having me.
Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. , based on recent data from the CDC.
Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.
Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.
What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.
Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.
Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).
There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.
Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
Addressing the synthetic opioid crisis
Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.
In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?
Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.
Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.
Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?
Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.
Fentanyl test strips
Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.
Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.
Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.
The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.
Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?
Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.
Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?
Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.
It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
Vaccines to combat the synthetic opioid crisis
Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?
Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.
Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.
Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?
Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.
Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.
One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.
Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.
Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?
Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.
Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.
Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.
A version of this article first appeared on Medscape.com.
This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.
Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.
Welcome, Dr Christo.
Paul J. Christo, MD, MBA: Thanks so much for having me.
Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. , based on recent data from the CDC.
Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.
Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.
What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.
Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.
Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).
There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.
Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
Addressing the synthetic opioid crisis
Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.
In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?
Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.
Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.
Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?
Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.
Fentanyl test strips
Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.
Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.
Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.
The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.
Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?
Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.
Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?
Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.
It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
Vaccines to combat the synthetic opioid crisis
Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?
Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.
Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.
Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?
Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.
Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.
One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.
Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.
Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?
Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.
Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.
Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.
A version of this article first appeared on Medscape.com.
Heart failure drug a new treatment option for alcoholism?
(AUD), new research suggests.
Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.
Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.
They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.
“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.
The study was published online in Molecular Psychiatry.
There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”
“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.
Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”
Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.
Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.
In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.
They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.
Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).
Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.
The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
New targets
Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).
Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).
In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).
Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.
In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).
In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.
The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.
“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.
“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.
Exciting findings
Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”
“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.
Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.
This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(AUD), new research suggests.
Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.
Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.
They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.
“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.
The study was published online in Molecular Psychiatry.
There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”
“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.
Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”
Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.
Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.
In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.
They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.
Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).
Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.
The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
New targets
Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).
Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).
In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).
Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.
In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).
In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.
The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.
“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.
“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.
Exciting findings
Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”
“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.
Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.
This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.
A version of this article first appeared on Medscape.com.
(AUD), new research suggests.
Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.
Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.
They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.
“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.
The study was published online in Molecular Psychiatry.
There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”
“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.
Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”
Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.
Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.
In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.
They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.
Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).
Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.
The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
New targets
Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).
Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).
In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).
Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.
In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).
In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.
The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.
“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.
“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.
Exciting findings
Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”
“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.
Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.
This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MOLECULAR PSYCHIATRY
Minorities hit especially hard by overdose deaths during COVID
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
The results underscore the “urgency of expanding prevention, treatment, and harm reduction interventions tailored to specific populations, especially American Indian or Alaska Native and Black populations, given long-standing structural racism and inequities in accessing these services,” the researchers note.
The study was published online in JAMA Network Open.
‘Urgent need’ for education
From February 2020 to August 2021, drug overdose deaths in the United States rose 37%, and these deaths were largely due to synthetic opioids other than methadone – primarily fentanyl or analogs – and methamphetamine.
Yet, data are lacking regarding racial and ethnic disparities in overdose death rates.
To investigate, Beth Han, MD, PhD, with the National Institute on Drug Abuse, and colleagues analyzed federal drug overdose death data for individuals aged 15-34 and 35-64 from March 2018 to August 2021.
Among individuals aged 15-34, from March 2018 to August 2021, overdose death rates involving any drug, fentanyl, and methamphetamine with or without fentanyl, increased overall.
For the 6 months from March to August 2021, non-Hispanic Native American or Alaska Native men had the highest rates overall involving any drug, fentanyl, and methamphetamine without fentanyl, with rates of 42.0, 30.2, and 6.0 per 100,000, respectively.
The highest rates (per 100,000) of drug overdose deaths involving methamphetamine with fentanyl were for Native American or Alaska Native men (9.2) and women (8.0) and non-Hispanic White men (6.7).
Among people aged 35-64, from March to August 2021, overall drug overdose rates (per 100,000) were highest among non-Hispanic Black men (61.2) and Native American or Alaska Native men (60.0), and fentanyl-involved death rates were highest among Black men (43.3).
Rates involving methamphetamine with fentanyl were highest among Native American or Alaska Native men (12.6) and women (9.4) and White men (9.5).
Rates involving methamphetamine without fentanyl were highest among Native American or Alaska Native men (22.9).
The researchers note the findings highlight the “urgent need” for education on dangers of methamphetamine and fentanyl.
Expanding access to naloxone, fentanyl test strips, and treatments for substance use disorders to disproportionately affected populations is also critical to help curb disparities in drug overdose deaths, they add.
Limitations of the study are that overdose deaths may be underestimated because of the use of 2021 provisional data and that racial or ethnic identification may be misclassified, especially for Native American or Alaska Native people.
This study was sponsored by the National Institute on Drug Abuse of the National Institutes of Health and the Centers for Disease Control and Prevention. The authors report no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Urgent need for research into psychedelic therapy for older adults
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
new research shows.
“Geriatric psychiatrists and others caring for older adults are interested in how much is known about psychedelic use in older adults,” study investigator C. Bree Johnston, MD, MPH, University of Arizona, Tucson, told this news organization.
“A major concern is how safe psychedelic-assisted therapy is for patients with heart disease, hypertension, neurological disorders, and multimorbidity,” Dr. Johnston said.
The study is published online in the American Journal of Geriatric Psychiatry.
‘Groundswell’ of research
The past few years have brought a “groundswell” of interest and promising research into the potential therapeutic benefit of psychedelic-assisted therapy for a variety of conditions affecting adults, the researchers noted.
They include psilocybin-assisted therapy for the distress associated with a terminal diagnosis, depression, and addiction, and MDMA-assisted therapy for PTSD.
However, in most studies, psychedelic therapy has been tested in relatively young healthy adults, raising the question of how generalizable the study results are for the patients that most geropsychiatrists will be treating, the investigators noted.
They reviewed “the most important” research studies on psilocybin- and MDMA-assisted therapies published over the past 2 decades that are likely to be relevant for geriatric psychiatrists and other professionals caring for older adults.
The researchers point out that psychedelics and related compounds have shown efficacy for the treatment of a number of conditions that are common among older adults, including mood disorders, distress associated with a serious medical illness, PTSD, substance use problems, and prolonged grief.
Psychedelics also have properties that may provide for cognitive impairment and dementia and promote personal growth among healthy older adults.
Research has shown that psychedelics can be safely administered to healthy adults in controlled conditions.
However, both psilocybin and MDMA can increase blood pressure and heart rate, which could be a concern if used in older adults with cardiovascular disease, the investigators noted.
“Healthy older adults are likely to face similar risks when undergoing psychedelic-assisted therapy as healthy younger adults,” said Dr. Johnston.
“In carefully selected adults, those risks appear to be minor when psychedelics are administered in controlled conditions under the guidance of a skilled therapist,” she added.
Given the potential of psychedelic compounds to benefit older adults, the authors call for more research to establish the safety and efficacy among older adults, particularly those with multiple comorbidities.
Pressing knowledge gaps
The exclusion of older adults from clinical trials of novel treatments is “one of contemporary psychiatry’s more pressing problems – one that extends beyond psychedelics,” Ipsit V. Vahia, MD, associate chief of the division of geriatric psychiatry, McLean Hospital, Belmont, Mass., who wasn’t involved in the review, told this news organization.
“Currently, there is little evidence that clinicians can lean on while considering the use of psychedelics in older adults,” Dr. Vahia said.
This paper highlights “the most pressing gaps in the evidence that bear addressing in order to develop more substantial best practices around the use of these drugs,” he added.
For example, little is known about appropriate dosing, pharmacokinetics, and pharmacodynamics of psychedelics in older adults, Dr. Vahia said.
“Their risks, particularly cardiovascular risks, are barely studied, and almost nothing is known about how these drugs may impact those in their 80s or older, or those with serious medical comorbidities who use multiple medications,” Dr. Vahia said. “The majority of the existing literature has excluded older adults, and the extremely limited evidence that does exist has been collected in relatively healthy, and relatively young (aged below 75) persons.”
Dr. Vahia noted that, before psychedelics as a class can be considered viable treatment options for a broader group of older adults, “more research is needed, particularly to establish safety.”
This research had no specific funding. Dr. Johnston and Dr. Vahia have no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY
Clozapine may be best choice for cutting SUD risk in schizophrenia
results of a real-world study show.
“Our findings are in line with a recent meta-analysis showing superior efficacy of clozapine in schizophrenia and comorbid SUD and other studies pointing toward clozapine’s superiority over other antipsychotics in the treatment of individuals with schizophrenia and comorbid SUD,” the investigators, led by Jari Tiihonen MD, PhD, department of clinical neuroscience, Karolinska Institutet, Stockholm, write.
“The results on polypharmacy are in line with previous results from nationwide cohorts showing a favorable outcome, compared with oral monotherapies among persons with schizophrenia in general,” they add.
The study was published online Aug. 25 in The British Journal of Psychiatry.
Research gap
Research on the effectiveness of pharmacotherapies for schizophrenia and comorbid SUD is “very sparse, and more importantly, non-existent on the prevention of the development of SUDs in patients with schizophrenia,” the researchers note.
To investigate, they analyzed data on more than 45,000 patients with schizophrenia from Finnish and Swedish national registries, with follow-up lasting 22 years in Finland and 11 years in Sweden.
In patients with schizophrenia without SUD, treatment with clozapine was associated with lowest risk for an initial SUD in both Finland (adjusted hazard ratio, 0.20; 95% confidence interval, 0.16-0.24) and Sweden (aHR, 0.35; 95% CI, 0.24-0.50), compared with no use or use of other antipsychotics.
In Finland, aripiprazole was associated with the second lowest risk for an initial SUD (aHR, 0.36; 95% CI, 0.24-0.55) and antipsychotic polytherapy the third lowest risk (aHR, 0.47; 95% CI, 0.42-0.53).
In Sweden, antipsychotic polytherapy was associated with second lowest risk for an initial SUD (aHR, 0.54; 95% CI, 0.44-0.66) and olanzapine the third lowest risk (aHR, 0.67; 95% CI, 0.53-0.84).
In both countries, the risk for relapse as indicated by psychiatric hospital admission and SUD-related hospital admission were lowest for clozapine, antipsychotic polytherapy and long-acting injectables, the investigators report.
Interpret with caution
Reached for comment, Christoph U. Correll, MD, professor of psychiatry and molecular medicine, the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, urged caution in interpreting the results.
“While the authors are experts in national database analyses and the study was conducted with state-of-the-art methodology, the onset of SUD analyses favoring clozapine are subject to survival bias and order effects,” Dr. Correll said.
“Since clozapine is generally used later in the illness and treatment course, after multiple other antipsychotics have been used, and since SUDs generally occur early in the illness course, most SUDs will already have arisen by the time that clozapine is considered and used,” Dr. Correll said.
“A similar potential bias exists for long-acting injectables (LAIs), as these have generally also been used late in the treatment algorithm,” he noted.
In terms of the significant reduction of SUD-related hospitalizations observed with clozapine, the “order effect” could also be relevant, Dr. Correll said, because over time, patients are less likely to be nonadherent and hospitalized and clozapine is systematically used later in life than other antipsychotics.
“Why antipsychotic polytherapy came out as the second-best treatment is much less clear. Clearly head-to-head randomized trials are needed to follow up on these interesting and intriguing naturalistic database study data,” said Dr. Correll.
This study was funded by the Finnish Ministry of Social Affairs and Health through the developmental fund for Niuvanniemi Hospital. Dr. Tiihonen and three co-authors have participated in research projects funded by grants from Janssen-Cilag and Eli Lilly to their institution. Dr. Correll reports having been a consultant and/or advisor to or receiving honoraria from many companies. He has also provided expert testimony for Janssen and Otsuka; served on a Data Safety Monitoring Board for Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva; received royalties from UpToDate; and is a stock option holder of Cardio Diagnostics, Mindpax, LB Pharma, and Quantic.
A version of this article first appeared on Medscape.com.
results of a real-world study show.
“Our findings are in line with a recent meta-analysis showing superior efficacy of clozapine in schizophrenia and comorbid SUD and other studies pointing toward clozapine’s superiority over other antipsychotics in the treatment of individuals with schizophrenia and comorbid SUD,” the investigators, led by Jari Tiihonen MD, PhD, department of clinical neuroscience, Karolinska Institutet, Stockholm, write.
“The results on polypharmacy are in line with previous results from nationwide cohorts showing a favorable outcome, compared with oral monotherapies among persons with schizophrenia in general,” they add.
The study was published online Aug. 25 in The British Journal of Psychiatry.
Research gap
Research on the effectiveness of pharmacotherapies for schizophrenia and comorbid SUD is “very sparse, and more importantly, non-existent on the prevention of the development of SUDs in patients with schizophrenia,” the researchers note.
To investigate, they analyzed data on more than 45,000 patients with schizophrenia from Finnish and Swedish national registries, with follow-up lasting 22 years in Finland and 11 years in Sweden.
In patients with schizophrenia without SUD, treatment with clozapine was associated with lowest risk for an initial SUD in both Finland (adjusted hazard ratio, 0.20; 95% confidence interval, 0.16-0.24) and Sweden (aHR, 0.35; 95% CI, 0.24-0.50), compared with no use or use of other antipsychotics.
In Finland, aripiprazole was associated with the second lowest risk for an initial SUD (aHR, 0.36; 95% CI, 0.24-0.55) and antipsychotic polytherapy the third lowest risk (aHR, 0.47; 95% CI, 0.42-0.53).
In Sweden, antipsychotic polytherapy was associated with second lowest risk for an initial SUD (aHR, 0.54; 95% CI, 0.44-0.66) and olanzapine the third lowest risk (aHR, 0.67; 95% CI, 0.53-0.84).
In both countries, the risk for relapse as indicated by psychiatric hospital admission and SUD-related hospital admission were lowest for clozapine, antipsychotic polytherapy and long-acting injectables, the investigators report.
Interpret with caution
Reached for comment, Christoph U. Correll, MD, professor of psychiatry and molecular medicine, the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, urged caution in interpreting the results.
“While the authors are experts in national database analyses and the study was conducted with state-of-the-art methodology, the onset of SUD analyses favoring clozapine are subject to survival bias and order effects,” Dr. Correll said.
“Since clozapine is generally used later in the illness and treatment course, after multiple other antipsychotics have been used, and since SUDs generally occur early in the illness course, most SUDs will already have arisen by the time that clozapine is considered and used,” Dr. Correll said.
“A similar potential bias exists for long-acting injectables (LAIs), as these have generally also been used late in the treatment algorithm,” he noted.
In terms of the significant reduction of SUD-related hospitalizations observed with clozapine, the “order effect” could also be relevant, Dr. Correll said, because over time, patients are less likely to be nonadherent and hospitalized and clozapine is systematically used later in life than other antipsychotics.
“Why antipsychotic polytherapy came out as the second-best treatment is much less clear. Clearly head-to-head randomized trials are needed to follow up on these interesting and intriguing naturalistic database study data,” said Dr. Correll.
This study was funded by the Finnish Ministry of Social Affairs and Health through the developmental fund for Niuvanniemi Hospital. Dr. Tiihonen and three co-authors have participated in research projects funded by grants from Janssen-Cilag and Eli Lilly to their institution. Dr. Correll reports having been a consultant and/or advisor to or receiving honoraria from many companies. He has also provided expert testimony for Janssen and Otsuka; served on a Data Safety Monitoring Board for Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva; received royalties from UpToDate; and is a stock option holder of Cardio Diagnostics, Mindpax, LB Pharma, and Quantic.
A version of this article first appeared on Medscape.com.
results of a real-world study show.
“Our findings are in line with a recent meta-analysis showing superior efficacy of clozapine in schizophrenia and comorbid SUD and other studies pointing toward clozapine’s superiority over other antipsychotics in the treatment of individuals with schizophrenia and comorbid SUD,” the investigators, led by Jari Tiihonen MD, PhD, department of clinical neuroscience, Karolinska Institutet, Stockholm, write.
“The results on polypharmacy are in line with previous results from nationwide cohorts showing a favorable outcome, compared with oral monotherapies among persons with schizophrenia in general,” they add.
The study was published online Aug. 25 in The British Journal of Psychiatry.
Research gap
Research on the effectiveness of pharmacotherapies for schizophrenia and comorbid SUD is “very sparse, and more importantly, non-existent on the prevention of the development of SUDs in patients with schizophrenia,” the researchers note.
To investigate, they analyzed data on more than 45,000 patients with schizophrenia from Finnish and Swedish national registries, with follow-up lasting 22 years in Finland and 11 years in Sweden.
In patients with schizophrenia without SUD, treatment with clozapine was associated with lowest risk for an initial SUD in both Finland (adjusted hazard ratio, 0.20; 95% confidence interval, 0.16-0.24) and Sweden (aHR, 0.35; 95% CI, 0.24-0.50), compared with no use or use of other antipsychotics.
In Finland, aripiprazole was associated with the second lowest risk for an initial SUD (aHR, 0.36; 95% CI, 0.24-0.55) and antipsychotic polytherapy the third lowest risk (aHR, 0.47; 95% CI, 0.42-0.53).
In Sweden, antipsychotic polytherapy was associated with second lowest risk for an initial SUD (aHR, 0.54; 95% CI, 0.44-0.66) and olanzapine the third lowest risk (aHR, 0.67; 95% CI, 0.53-0.84).
In both countries, the risk for relapse as indicated by psychiatric hospital admission and SUD-related hospital admission were lowest for clozapine, antipsychotic polytherapy and long-acting injectables, the investigators report.
Interpret with caution
Reached for comment, Christoph U. Correll, MD, professor of psychiatry and molecular medicine, the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, urged caution in interpreting the results.
“While the authors are experts in national database analyses and the study was conducted with state-of-the-art methodology, the onset of SUD analyses favoring clozapine are subject to survival bias and order effects,” Dr. Correll said.
“Since clozapine is generally used later in the illness and treatment course, after multiple other antipsychotics have been used, and since SUDs generally occur early in the illness course, most SUDs will already have arisen by the time that clozapine is considered and used,” Dr. Correll said.
“A similar potential bias exists for long-acting injectables (LAIs), as these have generally also been used late in the treatment algorithm,” he noted.
In terms of the significant reduction of SUD-related hospitalizations observed with clozapine, the “order effect” could also be relevant, Dr. Correll said, because over time, patients are less likely to be nonadherent and hospitalized and clozapine is systematically used later in life than other antipsychotics.
“Why antipsychotic polytherapy came out as the second-best treatment is much less clear. Clearly head-to-head randomized trials are needed to follow up on these interesting and intriguing naturalistic database study data,” said Dr. Correll.
This study was funded by the Finnish Ministry of Social Affairs and Health through the developmental fund for Niuvanniemi Hospital. Dr. Tiihonen and three co-authors have participated in research projects funded by grants from Janssen-Cilag and Eli Lilly to their institution. Dr. Correll reports having been a consultant and/or advisor to or receiving honoraria from many companies. He has also provided expert testimony for Janssen and Otsuka; served on a Data Safety Monitoring Board for Lundbeck, Relmada, Reviva, Rovi, Supernus, and Teva; received royalties from UpToDate; and is a stock option holder of Cardio Diagnostics, Mindpax, LB Pharma, and Quantic.
A version of this article first appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF PSYCHIATRY
Largest-ever study into the effects of cannabis on the brain
The largest-ever independent study into the effects of cannabis on the brain is being carried out in the United Kingdom.
Even though cannabis is the most commonly used illegal drug in the United Kingdom and medicinal cannabis has been legal there since 2018 little is known about why some people react badly to it and others seem to benefit from it.
According to Home Office figures on drug use from 2019, 7.6% of adults aged 16-59 used cannabis in the previous year.
Medicinal cannabis in the United Kingdom can only be prescribed if no other licensed medicine could help the patient. At the moment, GPs can’t prescribe it, only specialist hospital doctors can. The National Health Service says it can only be used in three circumstances: in rare, severe epilepsy; to deal with chemotherapy side effects such as nausea; or to help with multiple sclerosis.
As part of the Cannabis&Me study, KCL needs to get 3,000 current cannabis users and 3,000 non–cannabis users to take part in an online survey, with a third of those survey respondents then taking part in a face-to-face assessment that includes virtual reality (VR) and psychological analysis. The study also aims to determine how the DNA of cannabis users and their endocannabinoid system impacts their experiences, both negative and positive, with the drug.
The study is spearheaded by Marta Di Forti, MD, PhD, and has been allocated over £2.5 million in funding by the Medical Research Council.
This news organization asked Dr. Di Forti about the study.
Question: How do you describe the study?
Answer: “It’s a really unique study. We are aiming to see what’s happening to people using cannabis in the privacy of their homes for medicinal, recreational reasons, or whatever other reason.
“The debate on cannabis has always been quite polarized. There have been people who experience adversities with cannabis use, especially psychosis, whose families may perhaps like cannabis to be abolished if possible. Then there are other people who are saying they get positive benefits from using cannabis.”
Q: So where does the study come in?
A: “The study wants to bring the two sides of the argument together and understand what’s really happening. The group I see as a clinician comes to severe harm when they use cannabis regularly. We want to find out who they are and whether we can identify them. While we need to make sure they never come to harm when using cannabis, we need to consider others who won’t come to harm from using cannabis and give them a chance to use it in a way that’s beneficial.”
Q: How does the study work?
A: “The first step of the study is to use an online questionnaire that can be filled in by anyone aged 18-45 who lives in the London area or can travel here if selected. The first set of questions are a general idea of their cannabis use: ‘Why do they use it?’ ‘What are its benefits?’ Then, general questions on what their life has been like up to that point: ‘Did they have any adversities in childhood?’ ‘How is their mood and anxiety levels?’ ‘Do they experience any paranoid responses in everyday life?’ It probably takes between 30 and 40 minutes to fill out the questionnaire.”
Q: Can you explain about paranoid responses?
A: “We go through the questionnaires looking at people’s paranoid response to everyday life, not in a clinical disorder term, just in terms of the differences in how we respond to certain circumstances. For example: ‘How do you feel if someone’s staring at you on the Tube?’ Some people are afraid, some feel uncomfortable, some people don’t notice, and others think a person is staring at them as they look good or another such positive feeling. So, we give people a paranoia score and will invite some at the top and some at the bottom of that score for a face-to-face assessment. We want to select those people who are using cannabis daily and they are getting either no paranoia or high paranoia.”
Q: What happens at the face-to-face assessments?
A: “We do two things which are very novel. We ask them to take part in a virtual reality experience. They are in a lovely shop and within this experience they come across challenges, which may or may not induce a benign paranoia response. We will ask them to donate a sample of blood before they go into the VR set. We will test for tetrahydrocannabinol (THC) and cannabidiol (CBD). We will also look at the metabolites of the two. People don’t take into account how differently individuals metabolize cannabis, which could be one of the reasons why some people can tolerate it and others can’t.”
Q: There’s also a genetic aspect of the study?
A: “From the same sample, we will extract DNA to look at the genetics across the genome and compare genetic variations between high and low paranoia in the context of cannabis use. Also, we will look at the epigenetics, as we have learned from neuroscience, and also cancer, that sometimes a substance we ingest has an effect on our health. It’s perhaps an interaction with the way our DNA is written but also with the changes to the way our DNA is read and translated into biology if exposed to that substance. We know that smoking tobacco does have an impact at an epigenetic level on the DNA. We do know that in people who stop smoking, these impacts on the epigenetics are partially reversed. This work hasn’t been done properly for cannabis.
“There have been four published studies that have looked at the effect of cannabis use on epigenetics but they have been quite inconclusive, and they haven’t looked at large numbers of current users taking into account how much they are using. Moreover, we do know that when THC and CBD get into our bodies, they interact with something that is already embedded in our biology which is the endocannabinoid system. Therefore, in the blood samples we also aim to measures the levels of the endocannabinoids we naturally produce.
“All of this data will then be analyzed to see if we can get close to understanding what makes some cannabis users susceptible to paranoia while others who are using cannabis get some benefits, even in the domain of mental health.”
Q: Who are you looking for to take part in your study?
A: “What we don’t want is to get only people who are the classic friends and family of academics to do the study. We want a representative sample of people out there who are using cannabis. My ideal candidate would be someone who hates me and usually sends me abusive emails saying I’m against cannabis, which is wrong. All I want to find out is who is susceptible to harm which will keep everybody else safe. We are not trying to demonize cannabis; it’s exactly the opposite. We would like people from all ethnic and socioeconomic backgrounds to join to give voice to everyone out there using cannabis, the reasons why, and the effects they experience.”
Q: Will this study perhaps give more information of when it’s appropriate to prescribe medicinal cannabis, as it’s still quite unusual for it to be prescribed in the United Kingdom isn’t it?
A: “Absolutely spot on. That’s exactly the point. We want to hear from people who are receiving medicinal cannabis as a prescription, as they are likely to take it on a daily basis and daily use is what epidemiological studies have linked to the highest risk of psychosis. There will be people taking THC everyday for pain, nausea, for Crohn’s disease, and more.
“Normally when you receive a prescription for a medication the physician in charge will tell you the potential side effects which will be monitored to make sure it’s safe, and you may have to swap to a different medication. Now this isn’t really happening with medicinal cannabis, which is one of the reasons clinicians are anxious about prescribing it, and they have been criticized for not prescribing it very much. There’s much less structure and guidance about ‘psychosis-related’ side effects monitoring. If we can really identify those people who are likely to develop psychosis or disabling paranoia when they use cannabis, physicians might be more prepared to prescribe more widely when indicated.
“You could even have a virtual reality scenario available as a screening tool when you get prescribed medicinal cannabis, to see if there are changes in your perception of the world, which is ultimately what psychosis is about. Could this be a way of implementing safe prescribing which will encourage physicians to use safe cannabis compounds and make some people less anxious about it?
“This study is not here to highlight the negativity of cannabis, on the contrary it’s to understand how it can be used recreationally, but even more important, medicinally in a safe way so people that are coming to no harm can continue to do so and people who are at risk can be kept safe, or at least monitored adequately.”
A version of this article first appeared on Medscape UK.
The largest-ever independent study into the effects of cannabis on the brain is being carried out in the United Kingdom.
Even though cannabis is the most commonly used illegal drug in the United Kingdom and medicinal cannabis has been legal there since 2018 little is known about why some people react badly to it and others seem to benefit from it.
According to Home Office figures on drug use from 2019, 7.6% of adults aged 16-59 used cannabis in the previous year.
Medicinal cannabis in the United Kingdom can only be prescribed if no other licensed medicine could help the patient. At the moment, GPs can’t prescribe it, only specialist hospital doctors can. The National Health Service says it can only be used in three circumstances: in rare, severe epilepsy; to deal with chemotherapy side effects such as nausea; or to help with multiple sclerosis.
As part of the Cannabis&Me study, KCL needs to get 3,000 current cannabis users and 3,000 non–cannabis users to take part in an online survey, with a third of those survey respondents then taking part in a face-to-face assessment that includes virtual reality (VR) and psychological analysis. The study also aims to determine how the DNA of cannabis users and their endocannabinoid system impacts their experiences, both negative and positive, with the drug.
The study is spearheaded by Marta Di Forti, MD, PhD, and has been allocated over £2.5 million in funding by the Medical Research Council.
This news organization asked Dr. Di Forti about the study.
Question: How do you describe the study?
Answer: “It’s a really unique study. We are aiming to see what’s happening to people using cannabis in the privacy of their homes for medicinal, recreational reasons, or whatever other reason.
“The debate on cannabis has always been quite polarized. There have been people who experience adversities with cannabis use, especially psychosis, whose families may perhaps like cannabis to be abolished if possible. Then there are other people who are saying they get positive benefits from using cannabis.”
Q: So where does the study come in?
A: “The study wants to bring the two sides of the argument together and understand what’s really happening. The group I see as a clinician comes to severe harm when they use cannabis regularly. We want to find out who they are and whether we can identify them. While we need to make sure they never come to harm when using cannabis, we need to consider others who won’t come to harm from using cannabis and give them a chance to use it in a way that’s beneficial.”
Q: How does the study work?
A: “The first step of the study is to use an online questionnaire that can be filled in by anyone aged 18-45 who lives in the London area or can travel here if selected. The first set of questions are a general idea of their cannabis use: ‘Why do they use it?’ ‘What are its benefits?’ Then, general questions on what their life has been like up to that point: ‘Did they have any adversities in childhood?’ ‘How is their mood and anxiety levels?’ ‘Do they experience any paranoid responses in everyday life?’ It probably takes between 30 and 40 minutes to fill out the questionnaire.”
Q: Can you explain about paranoid responses?
A: “We go through the questionnaires looking at people’s paranoid response to everyday life, not in a clinical disorder term, just in terms of the differences in how we respond to certain circumstances. For example: ‘How do you feel if someone’s staring at you on the Tube?’ Some people are afraid, some feel uncomfortable, some people don’t notice, and others think a person is staring at them as they look good or another such positive feeling. So, we give people a paranoia score and will invite some at the top and some at the bottom of that score for a face-to-face assessment. We want to select those people who are using cannabis daily and they are getting either no paranoia or high paranoia.”
Q: What happens at the face-to-face assessments?
A: “We do two things which are very novel. We ask them to take part in a virtual reality experience. They are in a lovely shop and within this experience they come across challenges, which may or may not induce a benign paranoia response. We will ask them to donate a sample of blood before they go into the VR set. We will test for tetrahydrocannabinol (THC) and cannabidiol (CBD). We will also look at the metabolites of the two. People don’t take into account how differently individuals metabolize cannabis, which could be one of the reasons why some people can tolerate it and others can’t.”
Q: There’s also a genetic aspect of the study?
A: “From the same sample, we will extract DNA to look at the genetics across the genome and compare genetic variations between high and low paranoia in the context of cannabis use. Also, we will look at the epigenetics, as we have learned from neuroscience, and also cancer, that sometimes a substance we ingest has an effect on our health. It’s perhaps an interaction with the way our DNA is written but also with the changes to the way our DNA is read and translated into biology if exposed to that substance. We know that smoking tobacco does have an impact at an epigenetic level on the DNA. We do know that in people who stop smoking, these impacts on the epigenetics are partially reversed. This work hasn’t been done properly for cannabis.
“There have been four published studies that have looked at the effect of cannabis use on epigenetics but they have been quite inconclusive, and they haven’t looked at large numbers of current users taking into account how much they are using. Moreover, we do know that when THC and CBD get into our bodies, they interact with something that is already embedded in our biology which is the endocannabinoid system. Therefore, in the blood samples we also aim to measures the levels of the endocannabinoids we naturally produce.
“All of this data will then be analyzed to see if we can get close to understanding what makes some cannabis users susceptible to paranoia while others who are using cannabis get some benefits, even in the domain of mental health.”
Q: Who are you looking for to take part in your study?
A: “What we don’t want is to get only people who are the classic friends and family of academics to do the study. We want a representative sample of people out there who are using cannabis. My ideal candidate would be someone who hates me and usually sends me abusive emails saying I’m against cannabis, which is wrong. All I want to find out is who is susceptible to harm which will keep everybody else safe. We are not trying to demonize cannabis; it’s exactly the opposite. We would like people from all ethnic and socioeconomic backgrounds to join to give voice to everyone out there using cannabis, the reasons why, and the effects they experience.”
Q: Will this study perhaps give more information of when it’s appropriate to prescribe medicinal cannabis, as it’s still quite unusual for it to be prescribed in the United Kingdom isn’t it?
A: “Absolutely spot on. That’s exactly the point. We want to hear from people who are receiving medicinal cannabis as a prescription, as they are likely to take it on a daily basis and daily use is what epidemiological studies have linked to the highest risk of psychosis. There will be people taking THC everyday for pain, nausea, for Crohn’s disease, and more.
“Normally when you receive a prescription for a medication the physician in charge will tell you the potential side effects which will be monitored to make sure it’s safe, and you may have to swap to a different medication. Now this isn’t really happening with medicinal cannabis, which is one of the reasons clinicians are anxious about prescribing it, and they have been criticized for not prescribing it very much. There’s much less structure and guidance about ‘psychosis-related’ side effects monitoring. If we can really identify those people who are likely to develop psychosis or disabling paranoia when they use cannabis, physicians might be more prepared to prescribe more widely when indicated.
“You could even have a virtual reality scenario available as a screening tool when you get prescribed medicinal cannabis, to see if there are changes in your perception of the world, which is ultimately what psychosis is about. Could this be a way of implementing safe prescribing which will encourage physicians to use safe cannabis compounds and make some people less anxious about it?
“This study is not here to highlight the negativity of cannabis, on the contrary it’s to understand how it can be used recreationally, but even more important, medicinally in a safe way so people that are coming to no harm can continue to do so and people who are at risk can be kept safe, or at least monitored adequately.”
A version of this article first appeared on Medscape UK.
The largest-ever independent study into the effects of cannabis on the brain is being carried out in the United Kingdom.
Even though cannabis is the most commonly used illegal drug in the United Kingdom and medicinal cannabis has been legal there since 2018 little is known about why some people react badly to it and others seem to benefit from it.
According to Home Office figures on drug use from 2019, 7.6% of adults aged 16-59 used cannabis in the previous year.
Medicinal cannabis in the United Kingdom can only be prescribed if no other licensed medicine could help the patient. At the moment, GPs can’t prescribe it, only specialist hospital doctors can. The National Health Service says it can only be used in three circumstances: in rare, severe epilepsy; to deal with chemotherapy side effects such as nausea; or to help with multiple sclerosis.
As part of the Cannabis&Me study, KCL needs to get 3,000 current cannabis users and 3,000 non–cannabis users to take part in an online survey, with a third of those survey respondents then taking part in a face-to-face assessment that includes virtual reality (VR) and psychological analysis. The study also aims to determine how the DNA of cannabis users and their endocannabinoid system impacts their experiences, both negative and positive, with the drug.
The study is spearheaded by Marta Di Forti, MD, PhD, and has been allocated over £2.5 million in funding by the Medical Research Council.
This news organization asked Dr. Di Forti about the study.
Question: How do you describe the study?
Answer: “It’s a really unique study. We are aiming to see what’s happening to people using cannabis in the privacy of their homes for medicinal, recreational reasons, or whatever other reason.
“The debate on cannabis has always been quite polarized. There have been people who experience adversities with cannabis use, especially psychosis, whose families may perhaps like cannabis to be abolished if possible. Then there are other people who are saying they get positive benefits from using cannabis.”
Q: So where does the study come in?
A: “The study wants to bring the two sides of the argument together and understand what’s really happening. The group I see as a clinician comes to severe harm when they use cannabis regularly. We want to find out who they are and whether we can identify them. While we need to make sure they never come to harm when using cannabis, we need to consider others who won’t come to harm from using cannabis and give them a chance to use it in a way that’s beneficial.”
Q: How does the study work?
A: “The first step of the study is to use an online questionnaire that can be filled in by anyone aged 18-45 who lives in the London area or can travel here if selected. The first set of questions are a general idea of their cannabis use: ‘Why do they use it?’ ‘What are its benefits?’ Then, general questions on what their life has been like up to that point: ‘Did they have any adversities in childhood?’ ‘How is their mood and anxiety levels?’ ‘Do they experience any paranoid responses in everyday life?’ It probably takes between 30 and 40 minutes to fill out the questionnaire.”
Q: Can you explain about paranoid responses?
A: “We go through the questionnaires looking at people’s paranoid response to everyday life, not in a clinical disorder term, just in terms of the differences in how we respond to certain circumstances. For example: ‘How do you feel if someone’s staring at you on the Tube?’ Some people are afraid, some feel uncomfortable, some people don’t notice, and others think a person is staring at them as they look good or another such positive feeling. So, we give people a paranoia score and will invite some at the top and some at the bottom of that score for a face-to-face assessment. We want to select those people who are using cannabis daily and they are getting either no paranoia or high paranoia.”
Q: What happens at the face-to-face assessments?
A: “We do two things which are very novel. We ask them to take part in a virtual reality experience. They are in a lovely shop and within this experience they come across challenges, which may or may not induce a benign paranoia response. We will ask them to donate a sample of blood before they go into the VR set. We will test for tetrahydrocannabinol (THC) and cannabidiol (CBD). We will also look at the metabolites of the two. People don’t take into account how differently individuals metabolize cannabis, which could be one of the reasons why some people can tolerate it and others can’t.”
Q: There’s also a genetic aspect of the study?
A: “From the same sample, we will extract DNA to look at the genetics across the genome and compare genetic variations between high and low paranoia in the context of cannabis use. Also, we will look at the epigenetics, as we have learned from neuroscience, and also cancer, that sometimes a substance we ingest has an effect on our health. It’s perhaps an interaction with the way our DNA is written but also with the changes to the way our DNA is read and translated into biology if exposed to that substance. We know that smoking tobacco does have an impact at an epigenetic level on the DNA. We do know that in people who stop smoking, these impacts on the epigenetics are partially reversed. This work hasn’t been done properly for cannabis.
“There have been four published studies that have looked at the effect of cannabis use on epigenetics but they have been quite inconclusive, and they haven’t looked at large numbers of current users taking into account how much they are using. Moreover, we do know that when THC and CBD get into our bodies, they interact with something that is already embedded in our biology which is the endocannabinoid system. Therefore, in the blood samples we also aim to measures the levels of the endocannabinoids we naturally produce.
“All of this data will then be analyzed to see if we can get close to understanding what makes some cannabis users susceptible to paranoia while others who are using cannabis get some benefits, even in the domain of mental health.”
Q: Who are you looking for to take part in your study?
A: “What we don’t want is to get only people who are the classic friends and family of academics to do the study. We want a representative sample of people out there who are using cannabis. My ideal candidate would be someone who hates me and usually sends me abusive emails saying I’m against cannabis, which is wrong. All I want to find out is who is susceptible to harm which will keep everybody else safe. We are not trying to demonize cannabis; it’s exactly the opposite. We would like people from all ethnic and socioeconomic backgrounds to join to give voice to everyone out there using cannabis, the reasons why, and the effects they experience.”
Q: Will this study perhaps give more information of when it’s appropriate to prescribe medicinal cannabis, as it’s still quite unusual for it to be prescribed in the United Kingdom isn’t it?
A: “Absolutely spot on. That’s exactly the point. We want to hear from people who are receiving medicinal cannabis as a prescription, as they are likely to take it on a daily basis and daily use is what epidemiological studies have linked to the highest risk of psychosis. There will be people taking THC everyday for pain, nausea, for Crohn’s disease, and more.
“Normally when you receive a prescription for a medication the physician in charge will tell you the potential side effects which will be monitored to make sure it’s safe, and you may have to swap to a different medication. Now this isn’t really happening with medicinal cannabis, which is one of the reasons clinicians are anxious about prescribing it, and they have been criticized for not prescribing it very much. There’s much less structure and guidance about ‘psychosis-related’ side effects monitoring. If we can really identify those people who are likely to develop psychosis or disabling paranoia when they use cannabis, physicians might be more prepared to prescribe more widely when indicated.
“You could even have a virtual reality scenario available as a screening tool when you get prescribed medicinal cannabis, to see if there are changes in your perception of the world, which is ultimately what psychosis is about. Could this be a way of implementing safe prescribing which will encourage physicians to use safe cannabis compounds and make some people less anxious about it?
“This study is not here to highlight the negativity of cannabis, on the contrary it’s to understand how it can be used recreationally, but even more important, medicinally in a safe way so people that are coming to no harm can continue to do so and people who are at risk can be kept safe, or at least monitored adequately.”
A version of this article first appeared on Medscape UK.
Psychiatrists’ views on psychoactive drugs clash with U.S. policy
“The consensus among experts, including psychiatrists, about specific drugs is not consistent or congruent with the schedule of these drugs” in the United States, lead author Adam Levin, MD, third-year psychiatry resident, Ohio State University, Columbus, and affiliate scholar at the Center for Psychedelic Drug Research and Education, Ohio State College of Social Work, told this news organization.
Dr. Levin stressed the importance of appropriate drug scheduling to improve access to treatments such as psilocybin (psychedelic mushrooms) and 4-methylenedioxy methamphetamine (MDMA), which are now being tested for psychiatric disorders.
“We are in the middle of a mental health crisis so having any new tools would be really important,” he said.
The survey findings were published online in the International Journal of Drug Policy.
Five drug schedules
The Controlled Substances Act of 1970 created five “schedules” that organized drugs from most to least dangerous (schedule I-V). However, Dr. Levin said that the schedules do not accurately reflect the harms or therapeutic benefits of the various drugs.
Some drugs in lower, less restrictive schedules have greater potential for harm than do those in higher schedules, he noted. For example, methamphetamine, which has been recalled in multiple formulations because of concerns about abuse and limited medical use, remains a schedule II drug.
In addition, several schedule I drugs, including psilocybin and MDMA that are deemed dangerous and of no medical value, have shown therapeutic potential and low rates of misuse, addiction, or physical harm, the investigators noted.
In fact, the Food and Drug Administration has granted breakthrough therapy status to psilocybin for treatment-resistant depression and major depressive disorder (MDD) and to MDMA for posttraumatic stress disorder. This has positioned these drugs for possible FDA approval within the next few years.
Access to schedule I drugs for research purposes is tightly controlled. “Once psilocybin was placed in schedule I, there was this massive drop-off in the research funding and amount of research; and we’re just now starting to understand the potential therapeutic value of this drug,” said Dr. Levin.
Even with a recent research resurgence, most studies are funded by charitable donations or for-profit companies because of continued hesitancy on the part of grant-making organizations, he added.
Apparent contradictions
Given the pending approval of several schedule I drugs and escalating abuse of drugs in lower schedules, there is a growing need to understand physician attitudes surrounding the apparent contradictions in the drug schedule, the investigators noted.
Their survey included a geographically diverse group of 181 mostly middle-aged psychiatrists (65.2% were men) with an average of 16.2 years of practice after residency.
Participants were randomly assigned to respond to a vignette depicting a clinical scenario where a patient wants one of four drugs to help treat severe depression: psilocybin, a schedule I drug; methamphetamine (Desoxyn), a schedule II drug; ketamine, a Schedule III drug; or alprazolam (Xanax), a schedule IV drug.
Each of these therapies has established antidepressant properties, but none are FDA approved for treatment of MDD. However, an intranasal formulation of the ketamine enantiomer Spravato (esketamine) was recently approved for treatment-resistant depression.
There were significant differences among the groups presented with different vignettes. Participants were more likely to warn against repeated use of and development of a new psychiatric problem with methamphetamine and alprazolam compared with psilocybin or ketamine.
Respondents were most concerned about increased suicide risk after the nonprescribed use of alprazolam compared with psilocybin and ketamine.
Compared with all other drugs, ketamine was more likely to be integrated into treatment plans.
Therapeutic value, abuse potential
Participants were asked to rate the safety, therapeutic value, and abuse potential of the four drugs as well as alcohol, a nonscheduled legal drug, if used properly or as directed.
Respondents viewed psilocybin and ketamine as similarly safe – and safer than methamphetamine and alprazolam. They considered ketamine as having the highest therapeutic potential, followed by psilocybin, and then alprazolam and methamphetamine. “Last was alcohol, which we expected because alcohol is not used therapeutically,” said Dr. Levin.
Survey completers viewed methamphetamine, alprazolam, and alcohol as having similarly high abuse potential, and ketamine as having mid-level abuse potential. Psilocybin was rated as having the lowest abuse potential, “which is exactly the opposite of what is implied by its schedule I status,” noted Dr. Levin.
The results provide evidence these drugs “are incorrectly scheduled,” he said.
“This suggests the schedule does not reflect current evidence, which I think is really important to understand because there are consequences to the drug schedule,” including criminal justice and research consequences, he added.
Dr. Levin pointed out that possession of drugs in more harmful schedules is linked to sometimes lengthy prison sentences.
The psychiatrists’ perceptions of the drugs “overlaps pretty significantly” with recent surveys of other mental health professionals, including psychologists and addiction experts, he noted.
The study was funded by the Drug Enforcement and Policy Center, Moritz College of Law, and The Ohio State University. Dr. Levin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The consensus among experts, including psychiatrists, about specific drugs is not consistent or congruent with the schedule of these drugs” in the United States, lead author Adam Levin, MD, third-year psychiatry resident, Ohio State University, Columbus, and affiliate scholar at the Center for Psychedelic Drug Research and Education, Ohio State College of Social Work, told this news organization.
Dr. Levin stressed the importance of appropriate drug scheduling to improve access to treatments such as psilocybin (psychedelic mushrooms) and 4-methylenedioxy methamphetamine (MDMA), which are now being tested for psychiatric disorders.
“We are in the middle of a mental health crisis so having any new tools would be really important,” he said.
The survey findings were published online in the International Journal of Drug Policy.
Five drug schedules
The Controlled Substances Act of 1970 created five “schedules” that organized drugs from most to least dangerous (schedule I-V). However, Dr. Levin said that the schedules do not accurately reflect the harms or therapeutic benefits of the various drugs.
Some drugs in lower, less restrictive schedules have greater potential for harm than do those in higher schedules, he noted. For example, methamphetamine, which has been recalled in multiple formulations because of concerns about abuse and limited medical use, remains a schedule II drug.
In addition, several schedule I drugs, including psilocybin and MDMA that are deemed dangerous and of no medical value, have shown therapeutic potential and low rates of misuse, addiction, or physical harm, the investigators noted.
In fact, the Food and Drug Administration has granted breakthrough therapy status to psilocybin for treatment-resistant depression and major depressive disorder (MDD) and to MDMA for posttraumatic stress disorder. This has positioned these drugs for possible FDA approval within the next few years.
Access to schedule I drugs for research purposes is tightly controlled. “Once psilocybin was placed in schedule I, there was this massive drop-off in the research funding and amount of research; and we’re just now starting to understand the potential therapeutic value of this drug,” said Dr. Levin.
Even with a recent research resurgence, most studies are funded by charitable donations or for-profit companies because of continued hesitancy on the part of grant-making organizations, he added.
Apparent contradictions
Given the pending approval of several schedule I drugs and escalating abuse of drugs in lower schedules, there is a growing need to understand physician attitudes surrounding the apparent contradictions in the drug schedule, the investigators noted.
Their survey included a geographically diverse group of 181 mostly middle-aged psychiatrists (65.2% were men) with an average of 16.2 years of practice after residency.
Participants were randomly assigned to respond to a vignette depicting a clinical scenario where a patient wants one of four drugs to help treat severe depression: psilocybin, a schedule I drug; methamphetamine (Desoxyn), a schedule II drug; ketamine, a Schedule III drug; or alprazolam (Xanax), a schedule IV drug.
Each of these therapies has established antidepressant properties, but none are FDA approved for treatment of MDD. However, an intranasal formulation of the ketamine enantiomer Spravato (esketamine) was recently approved for treatment-resistant depression.
There were significant differences among the groups presented with different vignettes. Participants were more likely to warn against repeated use of and development of a new psychiatric problem with methamphetamine and alprazolam compared with psilocybin or ketamine.
Respondents were most concerned about increased suicide risk after the nonprescribed use of alprazolam compared with psilocybin and ketamine.
Compared with all other drugs, ketamine was more likely to be integrated into treatment plans.
Therapeutic value, abuse potential
Participants were asked to rate the safety, therapeutic value, and abuse potential of the four drugs as well as alcohol, a nonscheduled legal drug, if used properly or as directed.
Respondents viewed psilocybin and ketamine as similarly safe – and safer than methamphetamine and alprazolam. They considered ketamine as having the highest therapeutic potential, followed by psilocybin, and then alprazolam and methamphetamine. “Last was alcohol, which we expected because alcohol is not used therapeutically,” said Dr. Levin.
Survey completers viewed methamphetamine, alprazolam, and alcohol as having similarly high abuse potential, and ketamine as having mid-level abuse potential. Psilocybin was rated as having the lowest abuse potential, “which is exactly the opposite of what is implied by its schedule I status,” noted Dr. Levin.
The results provide evidence these drugs “are incorrectly scheduled,” he said.
“This suggests the schedule does not reflect current evidence, which I think is really important to understand because there are consequences to the drug schedule,” including criminal justice and research consequences, he added.
Dr. Levin pointed out that possession of drugs in more harmful schedules is linked to sometimes lengthy prison sentences.
The psychiatrists’ perceptions of the drugs “overlaps pretty significantly” with recent surveys of other mental health professionals, including psychologists and addiction experts, he noted.
The study was funded by the Drug Enforcement and Policy Center, Moritz College of Law, and The Ohio State University. Dr. Levin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The consensus among experts, including psychiatrists, about specific drugs is not consistent or congruent with the schedule of these drugs” in the United States, lead author Adam Levin, MD, third-year psychiatry resident, Ohio State University, Columbus, and affiliate scholar at the Center for Psychedelic Drug Research and Education, Ohio State College of Social Work, told this news organization.
Dr. Levin stressed the importance of appropriate drug scheduling to improve access to treatments such as psilocybin (psychedelic mushrooms) and 4-methylenedioxy methamphetamine (MDMA), which are now being tested for psychiatric disorders.
“We are in the middle of a mental health crisis so having any new tools would be really important,” he said.
The survey findings were published online in the International Journal of Drug Policy.
Five drug schedules
The Controlled Substances Act of 1970 created five “schedules” that organized drugs from most to least dangerous (schedule I-V). However, Dr. Levin said that the schedules do not accurately reflect the harms or therapeutic benefits of the various drugs.
Some drugs in lower, less restrictive schedules have greater potential for harm than do those in higher schedules, he noted. For example, methamphetamine, which has been recalled in multiple formulations because of concerns about abuse and limited medical use, remains a schedule II drug.
In addition, several schedule I drugs, including psilocybin and MDMA that are deemed dangerous and of no medical value, have shown therapeutic potential and low rates of misuse, addiction, or physical harm, the investigators noted.
In fact, the Food and Drug Administration has granted breakthrough therapy status to psilocybin for treatment-resistant depression and major depressive disorder (MDD) and to MDMA for posttraumatic stress disorder. This has positioned these drugs for possible FDA approval within the next few years.
Access to schedule I drugs for research purposes is tightly controlled. “Once psilocybin was placed in schedule I, there was this massive drop-off in the research funding and amount of research; and we’re just now starting to understand the potential therapeutic value of this drug,” said Dr. Levin.
Even with a recent research resurgence, most studies are funded by charitable donations or for-profit companies because of continued hesitancy on the part of grant-making organizations, he added.
Apparent contradictions
Given the pending approval of several schedule I drugs and escalating abuse of drugs in lower schedules, there is a growing need to understand physician attitudes surrounding the apparent contradictions in the drug schedule, the investigators noted.
Their survey included a geographically diverse group of 181 mostly middle-aged psychiatrists (65.2% were men) with an average of 16.2 years of practice after residency.
Participants were randomly assigned to respond to a vignette depicting a clinical scenario where a patient wants one of four drugs to help treat severe depression: psilocybin, a schedule I drug; methamphetamine (Desoxyn), a schedule II drug; ketamine, a Schedule III drug; or alprazolam (Xanax), a schedule IV drug.
Each of these therapies has established antidepressant properties, but none are FDA approved for treatment of MDD. However, an intranasal formulation of the ketamine enantiomer Spravato (esketamine) was recently approved for treatment-resistant depression.
There were significant differences among the groups presented with different vignettes. Participants were more likely to warn against repeated use of and development of a new psychiatric problem with methamphetamine and alprazolam compared with psilocybin or ketamine.
Respondents were most concerned about increased suicide risk after the nonprescribed use of alprazolam compared with psilocybin and ketamine.
Compared with all other drugs, ketamine was more likely to be integrated into treatment plans.
Therapeutic value, abuse potential
Participants were asked to rate the safety, therapeutic value, and abuse potential of the four drugs as well as alcohol, a nonscheduled legal drug, if used properly or as directed.
Respondents viewed psilocybin and ketamine as similarly safe – and safer than methamphetamine and alprazolam. They considered ketamine as having the highest therapeutic potential, followed by psilocybin, and then alprazolam and methamphetamine. “Last was alcohol, which we expected because alcohol is not used therapeutically,” said Dr. Levin.
Survey completers viewed methamphetamine, alprazolam, and alcohol as having similarly high abuse potential, and ketamine as having mid-level abuse potential. Psilocybin was rated as having the lowest abuse potential, “which is exactly the opposite of what is implied by its schedule I status,” noted Dr. Levin.
The results provide evidence these drugs “are incorrectly scheduled,” he said.
“This suggests the schedule does not reflect current evidence, which I think is really important to understand because there are consequences to the drug schedule,” including criminal justice and research consequences, he added.
Dr. Levin pointed out that possession of drugs in more harmful schedules is linked to sometimes lengthy prison sentences.
The psychiatrists’ perceptions of the drugs “overlaps pretty significantly” with recent surveys of other mental health professionals, including psychologists and addiction experts, he noted.
The study was funded by the Drug Enforcement and Policy Center, Moritz College of Law, and The Ohio State University. Dr. Levin reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF DRUG POLICY
How to identify and treat patients with substance use disorders
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
When Michael McGrath, MD, medical director of the Ohana Luxury Alcohol Rehab on the Big Island of Hawaii, trains primary care physicians, he tells them that talking with patients about substance use disorders is like having a stressful, weird conversation. But it’s a courageous one, because of the stigma associated with drug and alcohol disorders.
Dr. McGrath starts the conversation with patients by expressing that physicians now understand that addiction is a disease – one for which the patient isn’t responsible. He explains that there’s both a genetic and a nature/nurture component of the disorder and assures them that he won’t judge or abandon them but rather help them find treatment and make sure they get on the path to wellness.
It’s all too common to see patients with a substance use disorder in today’s primary care population. According to Medscape’s Physicians’ Views on Today’s Divisive Social Issues Report 2022,
According to the Recovery Research Institute, a leading nonprofit orgnaization from Massachusetts General Hospital dedicated to advancing addiction treatment and recovery, about 20 million people in the United States suffer from a substance use disorder. More than half (54%) need assistance with their recovery. The National Institute on Drug Abuse reports that substance abuse and addiction cost society more than $740 billion annually in workplace productivity, health care, and crime-related expenses.
Despite the challenges, physician experts provide advice on how to treat and help patients who have substance use disorders more effectively.
A courageous conversation
Often, the primary care physician or emergency physician is the first to be aware of a patient’s problem with a substance or a relapse. In many communities where shortages of specialized physicians and nonphysician treatment options for substance use disorders aren’t available, there’s usually limited time and resources to help patients with these disorders.
Patients often sense doctors are rushed and may not be interested in hearing about their drug or alcohol problems. Reddit threads are filled with stories like that of user “Cyralek,” who say that the two doctors they’ve seen since quitting drinking didn’t show much interest in the problem beyond ordering liver function tests.
In a nationwide study by researchers at Washington University School of Medicine, St. Louis, 80% of patients who met the diagnostic criteria for substance use disorder visited a doctor, hospital, or clinic for some reason over the past year. Only 1 in 10 were encouraged to cut back on drinking or receive any form of treatment or referral for substance misuse.
Emma Gordon, founder of a salvage yard in Los Angeles, says she used to abuse alcohol and that it affected every aspect of her life. Her brother tried to intervene, but nothing worked until she finally told a physician. “I admitted my problem and felt incredibly calm when she reacted as though it was all normal. I believe that was my first step to becoming a better me. I was thankful I had gone to see a doctor,” says Ms. Gordon.
Though physicians in primary care may not have more than a 15-minute appointment slot, seizing the opportunity to initiate a substance use disorder conversation when warranted is crucial, says Dr. McGrath. The CAGE-AID screening tool, which includes questions such as, “Have you ever felt you ought to cut down on your drinking or drug use?” is an excellent starter. Dr. McGrath also advises primary care clinicians to lower the threshold of concern to a single positive answer rather than several.
Doctors aren’t necessarily rewarded for the time it takes to develop a rapport with patients and to have a conversation that leads to asking, “How much are you drinking?”
“The system in primary care isn’t set up that way,” said Lucy McBride, MD, an internist in Washington, D.C.
Patients don’t often ask for help
In a perfect world, patients struggling with a substance use disorder would present with a request to discontinue using drugs or alcohol, as Ms. Gordon did. While that does happen sometimes, the onus is on the physician to screen for substance misuse.
“Remember, this is the disease that tells you that you don’t have a disease,” Dr. McGrath says. He also says that the use of screening instruments is a bare minimum. When patients are in the throes of a substance use disorder, the prefrontal cortex doesn’t work effectively. Dr. McGrath says there’s an alteration of consciousness so that the patient doesn’t realize the extent of the disease. “Often simply asking the patient is falling far short. It’s the biggest mistake I see,” he says.
Self-reporting from the patient may be unreliable. “That would be like a patient coming in and saying, ‘My blood sugar is 700, and I want you to give me some insulin,’ ” Dr. McGrath says. Instead, clinicians in the field need a more objective measurement.
Perhaps that means asking the patient to bring in a significant other at the next visit or digging deeper into the conversation about alcohol and drugs and their role in the patient’s life. And to really have an impact, Dr. McGrath said, the clinician should talk to the patient about referral for further evaluation.
“You have to get collateral history; that’s the goldmine for the clinician,” Dr. McGrath says. “It may take a few more minutes or mean talking to a family member, but it can make the difference between life and death.”
“I am thankful to my doctor who discussed this [substance use disorder] with me in detail,” says Ronald Williams, another Angeleno who braved the difficult discussion with his doctor. Mr. Williams says his doctor explained it in a good way and that if the doctor hadn’t guided him empathetically, the conversation might not have gone as well.
“We check patients’ cholesterol. We get them on the scale. But there is no blood test to discover how much they’re drinking, no PCR to test for social anxiety, no MRI that distinguishes between their recreational marijuana use and marijuana abuse,” said Dr. McBride.
Check the prescription drugs they’re taking
Another thing Dr. McGrath recommends is for primary care physicians to check the prescription drug monitoring program (PDMP) database in their state to help be alerted to a patient with a substance use disorder. The CDC’s PMPD guidelines recommend that the clinician check on a patient every 3 months or each time they write an opioid prescription. Assigning a staff member or a nurse to check the database can help uncover a history of doctor-shopping or use of controlled substances.
“There’s been a lot of times I’ve gone on self-report, and I’ve been bamboozled because I don’t have a truth-o-meter, and I can’t tell when a patient is telling the truth,” says Dr. McGrath.
He is also a huge proponent of point-of-service screening. Patients can urinate in a cup that has amino assay strips on the side, like an immediate COVID-19 test, or they can spit into a saliva cup. “It’s really beneficial for the patient and the clinician to know right then at the point of service if there is a substance present and what it is,” Dr. McGrath said.
It can be part of the larger conversation once a problem with substances has been uncovered. The clinician can say something like, “Let’s see where you are right now today as far as what you have in your system and where we should go from here.”
Other barriers physicians face
Many physicians may feel unprepared to meet the needs of patients with substance use disorders or prescribe medication that blunts cravings and reduces the urge to drink without the need for special training. Scientists at the National Institutes of Health found that only 1.6% of people with a substance use disorder were prescribed medication to help control it.
In the largest study on how primary care physicians address substance use disorders, fewer than 20% described themselves as very prepared to identify alcoholism or illegal drug use. Since most patients prefer to seek treatment from their primary care doctor, at least initially, not being prepared is a problem.
Although referral for specialty addiction treatment is recommended for patients with severe substance use disorders, primary care physicians with appropriate experience, training, and support can provide some of these services. “In an ideal world I wouldn’t have to refer patients out, since they’re much more likely to talk with their primary care provider about sensitive, intimate topics,” says Dr. McBride.
The issue of reimbursement
Billing for substance use disorder counseling or coordination of care is still challenging, and how to get compensated remains a conundrum for many physicians. Reimbursement may not adequately compensate providers for the additional time and staff needed, but some changes have been positive.
For instance, the American Society for Addiction Medicine reports that in 2022, Medicare expanded the physician fee schedule for opioid and SUD counseling to include reimbursement for telemedicine services.
Learning the billing CPT codes for various addiction treatments and counseling, or having a billing service that understands them, is crucial to reimbursement and keeping revenue running smoothly.
At the very least, developing relationships with treatment centers and specialists in the community can help physicians with referrals and with determining the level of care needed. Physicians can help facilitate that care with routine reassessment and frequent follow-ups, as well as by requesting reports from the treatment facility, continuing treatment of medical conditions, and reinforcing the importance of continued substance use disorder treatment.
Dr. McBride says that primary care physicians can and should make their office a safe, blame-free medical home for patients with substance use disorders. “Patients also need to understand they should bring their whole selves to the doctor – to talk about their sleep, what they consume, their depression, and not just about alcohol, but their relationship with it, and other substances,” she says.
“There needs to be time to talk about it.”
A version of this article first appeared on Medscape.com.
DOJ: Indiana nurses allowed controlled substances during opioid recovery
, according to a statement released Sept. 1.
In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”
ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.
Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.
The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.
Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”
The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.
In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.
As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.
The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.
“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”
In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.
“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”
Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.
A version of this article first appeared on Medscape.com.
, according to a statement released Sept. 1.
In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”
ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.
Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.
The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.
Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”
The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.
In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.
As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.
The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.
“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”
In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.
“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”
Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.
A version of this article first appeared on Medscape.com.
, according to a statement released Sept. 1.
In March, the U.S. Department of Justice (DOJ) announced the findings of its investigation, stating that the board “violated the ADA by prohibiting nurses who take medication to treat OUD from participating in the Indiana State Nursing Assistance Program [ISNAP].”
ISNAP rehabilitates and monitors nurses with substance use disorders, and the nursing board contracts with vendors to administer the program. Nurses seeking recovery must typically enroll in ISNAP and complete the 1-year program to maintain an active nursing license or have a license reinstated.
Following the investigation, the nursing board was instructed to implement corrective measures, such as revising policies and handbooks and training nursing board staff and vendors on ADA guidelines and nondiscriminatory practices.
The state’s professional organization for nurses said the remediation efforts will help nurses who are struggling with opioid addiction.
Katherine Feley, DNP, RN, chief executive officer of the Indiana State Nurses Association, told this news organization, “Allowing nurses who take medication to treat OUD to remain on their medication when participating in [ISNAP] will avoid making nurses choose between their health and their profession. This improvement will increase access to treatment resources, enabling more nurses to complete treatment and progress toward a safe return to work.”
The DOJ opened an investigation after receiving a complaint from a nurse in which she alleged that she was denied participation in ISNAP because of her use of prescription medication for OUD. In 2013, while participating in a methadone maintenance program, the nurse was told she had to taper off the medication because ISNAP utilizes an “abstinence-based” model. Because of these restrictions, she could not complete the program, and her nursing license was suspended in late 2014.
In 2016, her physician prescribed a new medication, buprenorphine, and the nurse attempted to enroll in ISNAP again. The program vendor instructed her to taper off the drug within 3 months of enrollment, something her physician believed “would come with a significant risk of relapse [and possibly] death.” The nurse was unable to qualify for reinstatement of her license.
As part of the settlement, the nursing board has agreed to pay a total of $70,000 in damages to the complainant and report compliance with new guidelines to the DOJ every 6 months.
The DOJ says ISNAP’s OUD abstinence policy does not conform with the state’s statute, which mandates that substance abuse rehabilitation services be provided for nurses.
“Indiana may not deny individuals lifesaving medications, including medications that treat [OUD], based on stereotypes and misinformation,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said of the settlement. “Requiring nurses to stop taking prescribed medication as a condition of maintaining a nursing license violates the ADA and not only creates barriers to recovery but inappropriately limits employment opportunities based on disability.”
In April, the DOJ issued guidance for protecting the civil rights of people with OUD under the ADA to ensure that individuals seeking treatment or recovery can continue participating in society and the workplace.
“The opioid epidemic has greatly impacted professionals and families of all walks of life, and Indiana nurses have the right to seek medically approved treatment for [OUD] under federal law,” U.S. Attorney Zachary A. Myers, of the Southern District of Indiana, said of the settlement. “Following the Justice Department’s findings and the parties’ settlement agreement, Indiana must now enact policies to ensure that Hoosier nurses will not be forced to choose between their recovery and their livelihoods.”
Under the terms of the agreement, the nursing board must allow nurses who are taking OUD medication to participate in ISNAP when the medication is prescribed by a licensed practitioner as part of a medically necessary treatment plan and is incorporated into a recovery monitoring agreement.
A version of this article first appeared on Medscape.com.