Alcohol abstinence questioned as addiction treatment goal

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– Reductions in alcohol use bring about significant improvement in adverse consequences, mental health status, and quality of life, even if the reductions do not reach the level of abstinence, according to recent research presented at the annual meeting of the American Academy of Addiction Psychiatry.

The findings, experts say, demonstrate how a fixation on abstinence or elimination of all heavy drinking – the endpoints the Food and Drug Administration now require in pivotal clinical trials on alcohol use disorder (AUD) treatments – is shortsighted and can unnecessarily discourage people with alcohol use disorder from pursuing treatment.

“We need to think a little differently, or a little out of the box, from the way we’ve been thinking in the past,” said Raymond F. Anton, MD, professor of psychiatry at the Medical University of South Carolina in Charleston and chair of the Alcohol Clinical Trials Initiative (ACTIVE), a group advocating for a new endpoint that recognizes the benefits of lesser reductions in alcohol intake.

In a new analysis using data from the COMBINE study, researchers looked at the associations between reduction in World Health Organization drinking risk levels of alcohol consumption and clinically meaningful outcomes among people in treatment.

There are four levels: very high (more than 7.1 14-g drinks a day for men and more than 4.3 for women); high (4.3-7.1 or 2.9-4.3, respectively); moderate (2.9-4.3 or 1.4-2.9); and low (less than 2.9 or less than 1.4).

Researchers assessed responses to treatment with acamprosate, naltrexone, and psychological intervention in patients an average of 44 years old with 71% of their days being heavy drinking days. They found significant improvement in consequences tied to drinking, according to the Drinker Inventory of Consequences, and in mental health according to the Short Form Health Survey and the WHO Quality of Life assessment – even when the improvement was only by one WHO risk level – or just a few drinks a day – and did not involve abstaining (P less than .001 for all improvement categories).

“Reductions in WHO drinking risk levels are predictive of clinical benefit” or how the patient feels and functions, said Daniel Falk, PhD, health scientist administrator at the National Institute on Alcohol Abuse and Alcoholism.

The ACTIVE group he chairs, Dr. Anton said, is proposing that the FDA add a new endpoint for phase 3 trials: percentage of subjects who attain a 1- or 2-level reduction in WHO drinking risk levels.

Stephanie O’Malley, PhD, professor of psychiatry at Yale University in New Haven, Conn., said a 30-year-old with a moderate drinking problem – occasionally missing a family function, but never letting it interfere with work, say – might be turned off by a treatment plan that preaches abstinence, she said. Varenicline, for example, results in abstinence just 7% of the time, with some risk of suicidality and nausea. That person might not want to stop drinking entirely for the rest of his or her life, but could benefit by reducing the drinking, she said.

But 55% of the time, varenicline produces a reduction of one level of risk, which is associated with clinically meaningful results. That will sound much more appealing to a prospective patient, she said.

“From a clinical perspective, these WHO outcomes have some advantages,” she said. “I think you’re going to, one, encourage more people to accept treatment, and … be more optimistic about the outcomes.”

Dr. Anton reported consulting and/or funding from Alkermes, Allergan, Indivior, Insys Life Epigenetics, and Laboratori Farmaceutico CT. Dr. O’Malley reported consulting and/or funding from Alkermes, Amygdala, Indivior, Mistubishi Tanabe, Opiant, and other sources. Dr. Falk reported no disclosures.

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– Reductions in alcohol use bring about significant improvement in adverse consequences, mental health status, and quality of life, even if the reductions do not reach the level of abstinence, according to recent research presented at the annual meeting of the American Academy of Addiction Psychiatry.

The findings, experts say, demonstrate how a fixation on abstinence or elimination of all heavy drinking – the endpoints the Food and Drug Administration now require in pivotal clinical trials on alcohol use disorder (AUD) treatments – is shortsighted and can unnecessarily discourage people with alcohol use disorder from pursuing treatment.

“We need to think a little differently, or a little out of the box, from the way we’ve been thinking in the past,” said Raymond F. Anton, MD, professor of psychiatry at the Medical University of South Carolina in Charleston and chair of the Alcohol Clinical Trials Initiative (ACTIVE), a group advocating for a new endpoint that recognizes the benefits of lesser reductions in alcohol intake.

In a new analysis using data from the COMBINE study, researchers looked at the associations between reduction in World Health Organization drinking risk levels of alcohol consumption and clinically meaningful outcomes among people in treatment.

There are four levels: very high (more than 7.1 14-g drinks a day for men and more than 4.3 for women); high (4.3-7.1 or 2.9-4.3, respectively); moderate (2.9-4.3 or 1.4-2.9); and low (less than 2.9 or less than 1.4).

Researchers assessed responses to treatment with acamprosate, naltrexone, and psychological intervention in patients an average of 44 years old with 71% of their days being heavy drinking days. They found significant improvement in consequences tied to drinking, according to the Drinker Inventory of Consequences, and in mental health according to the Short Form Health Survey and the WHO Quality of Life assessment – even when the improvement was only by one WHO risk level – or just a few drinks a day – and did not involve abstaining (P less than .001 for all improvement categories).

“Reductions in WHO drinking risk levels are predictive of clinical benefit” or how the patient feels and functions, said Daniel Falk, PhD, health scientist administrator at the National Institute on Alcohol Abuse and Alcoholism.

The ACTIVE group he chairs, Dr. Anton said, is proposing that the FDA add a new endpoint for phase 3 trials: percentage of subjects who attain a 1- or 2-level reduction in WHO drinking risk levels.

Stephanie O’Malley, PhD, professor of psychiatry at Yale University in New Haven, Conn., said a 30-year-old with a moderate drinking problem – occasionally missing a family function, but never letting it interfere with work, say – might be turned off by a treatment plan that preaches abstinence, she said. Varenicline, for example, results in abstinence just 7% of the time, with some risk of suicidality and nausea. That person might not want to stop drinking entirely for the rest of his or her life, but could benefit by reducing the drinking, she said.

But 55% of the time, varenicline produces a reduction of one level of risk, which is associated with clinically meaningful results. That will sound much more appealing to a prospective patient, she said.

“From a clinical perspective, these WHO outcomes have some advantages,” she said. “I think you’re going to, one, encourage more people to accept treatment, and … be more optimistic about the outcomes.”

Dr. Anton reported consulting and/or funding from Alkermes, Allergan, Indivior, Insys Life Epigenetics, and Laboratori Farmaceutico CT. Dr. O’Malley reported consulting and/or funding from Alkermes, Amygdala, Indivior, Mistubishi Tanabe, Opiant, and other sources. Dr. Falk reported no disclosures.

 

– Reductions in alcohol use bring about significant improvement in adverse consequences, mental health status, and quality of life, even if the reductions do not reach the level of abstinence, according to recent research presented at the annual meeting of the American Academy of Addiction Psychiatry.

The findings, experts say, demonstrate how a fixation on abstinence or elimination of all heavy drinking – the endpoints the Food and Drug Administration now require in pivotal clinical trials on alcohol use disorder (AUD) treatments – is shortsighted and can unnecessarily discourage people with alcohol use disorder from pursuing treatment.

“We need to think a little differently, or a little out of the box, from the way we’ve been thinking in the past,” said Raymond F. Anton, MD, professor of psychiatry at the Medical University of South Carolina in Charleston and chair of the Alcohol Clinical Trials Initiative (ACTIVE), a group advocating for a new endpoint that recognizes the benefits of lesser reductions in alcohol intake.

In a new analysis using data from the COMBINE study, researchers looked at the associations between reduction in World Health Organization drinking risk levels of alcohol consumption and clinically meaningful outcomes among people in treatment.

There are four levels: very high (more than 7.1 14-g drinks a day for men and more than 4.3 for women); high (4.3-7.1 or 2.9-4.3, respectively); moderate (2.9-4.3 or 1.4-2.9); and low (less than 2.9 or less than 1.4).

Researchers assessed responses to treatment with acamprosate, naltrexone, and psychological intervention in patients an average of 44 years old with 71% of their days being heavy drinking days. They found significant improvement in consequences tied to drinking, according to the Drinker Inventory of Consequences, and in mental health according to the Short Form Health Survey and the WHO Quality of Life assessment – even when the improvement was only by one WHO risk level – or just a few drinks a day – and did not involve abstaining (P less than .001 for all improvement categories).

“Reductions in WHO drinking risk levels are predictive of clinical benefit” or how the patient feels and functions, said Daniel Falk, PhD, health scientist administrator at the National Institute on Alcohol Abuse and Alcoholism.

The ACTIVE group he chairs, Dr. Anton said, is proposing that the FDA add a new endpoint for phase 3 trials: percentage of subjects who attain a 1- or 2-level reduction in WHO drinking risk levels.

Stephanie O’Malley, PhD, professor of psychiatry at Yale University in New Haven, Conn., said a 30-year-old with a moderate drinking problem – occasionally missing a family function, but never letting it interfere with work, say – might be turned off by a treatment plan that preaches abstinence, she said. Varenicline, for example, results in abstinence just 7% of the time, with some risk of suicidality and nausea. That person might not want to stop drinking entirely for the rest of his or her life, but could benefit by reducing the drinking, she said.

But 55% of the time, varenicline produces a reduction of one level of risk, which is associated with clinically meaningful results. That will sound much more appealing to a prospective patient, she said.

“From a clinical perspective, these WHO outcomes have some advantages,” she said. “I think you’re going to, one, encourage more people to accept treatment, and … be more optimistic about the outcomes.”

Dr. Anton reported consulting and/or funding from Alkermes, Allergan, Indivior, Insys Life Epigenetics, and Laboratori Farmaceutico CT. Dr. O’Malley reported consulting and/or funding from Alkermes, Amygdala, Indivior, Mistubishi Tanabe, Opiant, and other sources. Dr. Falk reported no disclosures.

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Checklists, colleagues key when psychiatric patient overdoses

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BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

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BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

BONITA SPRINGS, FLA. — Specialized checklists and colleague support prove crucial to psychiatrists when one of their patients in treatment for substance use disorder dies from an overdose, an expert said at the Annual Meeting of the American Academy of Addiction Psychiatry.

Much of the knowledge about how psychiatrists are affected by overdose deaths, and what can help them handle them better, is drawn from the literature on patient suicide – both types of death are sudden and unexpected, and both involve stigma and can isolate the patients’ families and providers, said Amy Yule, MD, medical director of the Addiction Recovery Management Service at Massachusetts General Hospital in Boston.

“To our knowledge, the provider’s experience after an overdose has not been studied, and [there are] no practice guidelines to guide providers after an overdose death,” she said.

The overdose death of a patient is a particularly difficult matter because psychiatrists struggle with the emotional toll at the same time that they are dealing with fairly urgent details, including some with important legal implications, Dr. Yule said.

“Literature on the provider experience after suicide death indicates that providers are highly impacted by a patient’s suicide,” she said.

A key question is whether to contact the patient’s family. And generally, the answer should be yes.

“It’s really important to offer the option to meet with family members since these families may feel very isolated stigma as they grieve,” Dr. Yule said. What’s more, when families are not contacted by the physician, they might turn to litigation to try to seek information to help them understand their loss, she said.

In a survey of therapists whose patients died by suicide, 73% said they made contact with patient families and, in most instances, the family was not critical and expressed gratitude.

She emphasized the importance of knowing whether a patient’s family knew of the treatment. Because privacy laws extend after a patient’s death, providers cannot disclose treatment to families who did not already know, she said.

Also, she said, “communication with families should be focused on addressing the family members’ feelings and not the clinical details of the case.”

Most states have “apology statutes” that prevent expressions of sympathy – such as, “I’m sorry for your loss” – to be used as admission of liability, but providers should check the laws in their own states, she said.

If you have a colleague whose patient has overdosed or lost their lives to suicide, certain approaches are better than others, Dr. Yule said.

“It’s helpful when colleagues share their own experience with the suicide of a patient or patient who has overdosed and died,” she said. “What’s not helpful is the premature reassurance that the clinician has done nothing wrong. We may feel in these instances that we want to provide that premature reassurance, but it’s important not to do that because it doesn’t help providers resolve their grief.”

For solo providers, it’s especially important to be part of a physician network because they might otherwise not have the same support that those in larger organizations have, she said.

Beyond the grieving process, logistical details also need tending to, she said. The malpractice insurance carrier should be notified, even when there was no sign of a contentious interaction with the family. And, in her organization, the staff run down a checklist that includes not only calling the family and sending a condolence card, notifying staff promptly, and documenting the death, but also easily overlooked details like canceling future appointments in the scheduling system.

“You really don’t want a phone call going to the patient’s family with an appointment reminder after the patient is deceased,” Dr. Yule said. “These are the little details that you may not remember when you’re acutely grieving a patient’s death. And that’s why we feel it’s important to have a list.”

Dr. Yule reported no relevant disclosures.

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Technical issues inhibit data collection on fentanyl

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BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

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BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

BONITA SPRINGS, FLA. – Systemic gaps inhibit the collection of data that could be helpful in combating skyrocketing fentanyl use in the United States, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Jane C. Maxwell, PhD, research professor at the Addiction Research Institute at the University of Texas at Austin, pointed to the Treatment Episode Data Set as an example. It includes client-level information on substance-use treatment admissions from state agencies, and it could be a good source of fentanyl data. The problem? The admissions data do not have a category for fentanyl.

“So we don’t even know who the users are in that data set,” Dr. Maxwell said.

When it comes to mortality, the data on fentanyl are sometimes available, but they are cumbersome to collect, she said. “The only way to get at fentanyl in the mortality data – because you’re going to get it under ‘synthetic opiates’ – is to get the literal texts that are written on the death certificates.” That requires hand-counting the cases of fentanyl in order to know whether a death was attributable to fentanyl or some other drug.

The data that are available paint a grim picture, with drug-poisoning deaths from “other synthetics,” the category that includes fentanyl, soaring since 2013, surging past deaths from heroin as the top killer, according to the Centers for Disease Control and Prevention’s National Center for Health Statistics.

The number of drug cases involving fentanyl jumped to 60,670 in 2017, up from 11,992 in 2015, according to a report from the National Forensic Laboratory Information System.

Dr. Maxwell said when she first heard the word “enigma” used to describe the fentanyl phenomenon, she thought it was a curious word choice. But as she stepped back and looked at how deadly fentanyl is, and the gaps in what is really known about it, she reconsidered. “The more I look at what is going on with fentanyl, it is an ‘enigma,’ ” she said.

In addition, Sandra D. Comer, PhD, noted that in 2006 a spike in fentanyl cases was described as an “epidemic,” before falling again. By 2015, the number of cases involving fentanyl was 8 times that “epidemic” amount, driven not by pharmaceutical product but by synthetic versions of the drug.

“There are hundreds of labs now that are making fentanyl,” said Dr. Comer, professor of neurobiology in the department of psychiatry at Columbia University in New York. “This is why the [Drug Enforcement Administration] has stated that they think it’s a problem that’s not going to go away any time soon.”

Dr. Maxwell reported no relevant disclosures. Dr. Comer reported consulting and collaboration with several companies, including Alkermes, Janssen, Mallinckrodt, and Sun Pharmaceutical.

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Understanding properties of fentanyl, other opioids key to treatment

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Naloxone increasingly coming up short, expert says

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

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Naloxone increasingly coming up short, expert says

Naloxone increasingly coming up short, expert says

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

– Treating disorders tied to the use of highly potent synthetic opioids (HPSO), such as fentanyl, is challenging at best, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. John J. Mariani

“We have essentially no data to guide pharmacotherapy management decisions for the leading cause of fatal overdose deaths in the U.S.,” said John J. Mariani, MD, associate professor of clinical psychiatry at Columbia University, New York. “In the absence of data to make evidence-based recommendations, we still need to treat patients.”

That means taking what is known about the properties of those drugs into account when making treatment decisions, he said. Fentanyl quickly crosses the blood-brain barrier and is rapidly distributed to peripheral tissue. It has a short duration of action, but its duration can be extended with multiple injections or an infusion, he said. Research suggests that it has opioid receptor affinity similar to that of morphine, and it’s not known why it is up to 100 times more potent than morphine.

From his own experience, he offered some suggestions on treating patients who use HPSOs:

  • Buprenorphine: Clinicians using buprenorphine as induction treatment have to wait longer from the last use to the first dose because of its longer effective half-life, and other medications might be needed to manage withdrawal. For maintenance, higher doses possibly should be considered to prevent HPSO override and to maintain opioid tolerance.
  • Extended-release naltrexone: This involves a more difficult induction, and there is a question of whether inpatient treatment is better than outpatient, he said. For maintenance, more frequent administration should be considered, with closer monitoring for the risk of override and more urine toxicology testing.
  • Methadone: For induction, methadone could offer an advantage over buprenorphine, because there is no risk of precipitated withdrawal. For maintenance, Dr. Mariani said, it’s not known whether standard doses protect against raising tolerance out of the reach of HPSOs’ effects.
  • Naloxone: He said there have been increasing reports of multiple doses being needed to reverse an overdose. Because of the shorter time between substance use and death with fentanyl, more reports have been filed on unsuccessful attempts to revive people with naloxone despite multiple doses or stronger doses. Some naloxone programs have been giving more than two standard doses or using devices that give higher doses, he said. Also, since many users never intend to take fentanyl but are exposed to it through what they thought was heroin, communication is vital, he said.

Addiction psychiatrists “need to educate patients, families, and other clinicians of this new risk of using opioids,” he said.

Meanwhile, in another talk, Thomas Kosten, MD, described progress in the efforts to develop a vaccine against fentanyl addiction, in the hopes of preventing overdoses. Researchers are taking cues from the failed attempt to develop a cocaine vaccine a few years ago, in which not enough antibodies were produced in about half the patients.

Dr. Thomas Kosten


This time, researchers are using toll-like receptor agonists to boost the effects of the main vaccine component, known as norcocaine. Those agonists can more than double the antibody increase that is seen without them, said Dr. Kosten, professor of psychiatry at Baylor College of Medicine, Houston.

So far, researchers have found that the vaccine produces blockade of fentanyl analgesia and respiratory depression in rats. Dr. Kosten said his lab is looking for funding to continue the research. “It looks like we’re going to have some money in February to start making the vaccine,” he said.

Dr. Mariani and Dr. Kosten reported no relevant disclosures.

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Drug test results ‘should not dictate treatment’

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– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

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– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

– Urine drug screening is a vital part of clinical care, but many clinicians say they do not know enough about how the tests work, an expert said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Rebecca Payne

Rebecca Ann Payne, MD, said clinicians, including residents, tend to cite little training as a reason for their uncertainty about how to interpret urine drug screen results. Also, primary care clinicians say they need more education on implementing and interpreting the screens.

The good news is that medicine and pediatric residents said they felt that a 30-minute educational program significantly boosted their knowledge base and comfort in interpreting urine drug screens, said Dr. Payne, assistant professor of neuropsychiatry and behavioral science at Palmetto Health–University of South Carolina Medical Group. She offered several points that addiction psychiatrists should be aware of:

  • Be careful not to put too much stock in the results.

“A positive test doesn’t necessarily mean there’s a substance use disorder,” she said. “You still need to walk through those criteria with your patients. And a positive test doesn’t mean they’re physically dependent upon it.” She said she sometimes hears from patients who say that they’d been on a certain treatment – then failed a test given by their clinician – and had their treatment stripped away.

“Drug testing is meant to be a source of information and should not dictate treatment,” she said. “I have found it’s not unusual to hear from the community that decisions are being made solely on the results of these tests, which can be problematic.”

  • Point-of-care tests, which sometimes can be bought in drug stores, she said, are “much less than perfect.”

The false-positive rate for benzodiazepines has been found to be 61%; and for methadone, it is 46%; for opioids, 22%; and for amphetamines, 21%.

  • Know what your lab is actually testing for, because “it’s not universal.”

She emphasized knowing the particulars of opiate testing.

“A lot of times in a hospital setting, your lab is really only testing those opiates that are directly derived from the poppy – we’re talking about things like codeine, heroin, morphine. They’re not testing for things like your semi-synthetics or your full-synthetic opiates.”

  • Know the answer to the question: “Can you get a positive result on a marijuana drug screen just from passive inhalation?”

Physicians often will be confronted by patients who insist they were only in the car or in the same room with someone who was smoking marijuana. How likely is it that their test could be positive?

“Possible,” she said, “but not probable.”

Dr. Payne’s key interest areas include teaching medical students and residents, treating substance use and psychiatric disorders that are comorbid, and conducting research in addiction psychiatry.

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Rural teleprescribing for opioid use disorder shows success

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– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

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– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

– Clinician shortages and alarming opioid overdose rates are prompting rural health care centers to turn to telemedicine for delivering treatments for opioid use disorder (OUD). Several studies suggest that these treatments are being delivered effectively, experts said at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. David Moore

In both Maryland and West Virginia, for example, success using a telehealth approach has been reported recently, said David Moore, MD, PhD, assistant professor of psychiatry at Yale University, New Haven, Conn.

Specifically, in rural Maryland, physicians used telemedicine to provide buprenorphine treatment for OUD at a treatment center in August 2015. Researchers at the University of Maryland, Baltimore, looked at the first 177 of the patients treated with the approach. They found that retention in treatment was 91% at 1 month and 57% at 3 months. Of patients still in treatment at 3 months, 86% had urine that was opioid negative, researchers said (Am J Addict. 2018 Dec;27[8]:612-17).

And in West Virginia, researchers reviewed the records of 100 patients receiving buprenorphine treatment to compare outcomes of those treated with telemedicine and those treated face-to-face. They found no significant differences between the groups in additional substance use, time to achieve 30 days and 90 days of abstinence, or retention rates at 3 months and 1 year (J Addict Med. 2017 Mar-Apr;11[2]:138-44).

In addition, Dr. Moore said, he has had success with home inductions in the northern reaches of Maine. His first home induction involved a 55-year-old veteran with a history of oxycodone and hydrocodone use who used illicit buprenorphine when he could. Dr. Moore said the man was referred to him on a Monday. He called in a prescription for the drug the next day and gave the patient a handout on how to do a home induction. “Then he had a phone check-in, and we followed up on Thursday. It actually worked really well,” Dr. Moore said.

The dearth of buprenorphine providers in northern Maine makes those kinds of arrangements attractive, he said. In Maine’s Piscataquis County, he said, there is one buprenorphine provider for every 2,000 square miles. “We have about 1 in every 5 square miles in New Haven,” he said. “Thinking about the distance you have to travel, it gets to be pretty daunting.”

The ability of clinicians to provide buprenorphine with telemedicine varies by state. Among the resources needed to provide telemedicine services are reliable Internet access and an ability for a patient to consent to the treatment.

Nationwide, 56.3% of rural counties have no buprenorphine provider, according to a recent study, said Lewei (Allison) Lin, MD, assistant professor of psychiatry at the University of Michigan, Ann Arbor. A survey of 1,100 rural providers, results of which were included in that study, found that 48% of them said concerns about substance diversion or misuse were a barrier to providing buprenorphine, and 44% cited a lack of mental health or psychosocial support services.

“Although this country still has a major issue with access to treatment, we see that the access problem is about double in rural areas,” she said. “If you add on the distance issue and time, this becomes an even greater challenge.”

Nurse practitioners and physician assistants are now able to obtain a Drug Enforcement Administration waiver that will allow them to prescribe OUD, thanks to the Comprehensive Addiction and Recovery Act of 2016.

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Psilocybin yields encouraging results in addiction studies

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– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

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– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

– Small but tantalizing studies are showing benefits from treatment with psilocybin, the psychedelic substance, for alcohol and cocaine addiction, according to findings presented at the annual meeting of the American Academy of Addiction Psychiatry.

Dr. Michael Bogenshutz

Researchers emphasized that the results are in the early stages, and that treatment is administered only after careful patient screening and in controlled environments. In a proof-of-concept study of 10 patients, subjects with alcohol use disorder (AUD) underwent 12 weeks of psychosocial treatment, with two psilocybin “sessions” mixed in, at weeks 4 and 8. At baseline, 35% of the patients’ days were heavy drinking days, but by weeks 25-36, only about 12% were heavy drinking days, a significant reduction. Days with any drinking fell from just over 40% to about 15% over that period, also a significant drop, said Michael P. Bogenschutz, MD, professor of psychiatry at New York University, who is leading the research (J Psychopharmacol. 2015 Mar;29[3]:289-99).

In a current trial of more than 100 participants that he is leading, early data are available on the first 56 patients through 12 weeks. Patients have been treated with psilocybin or diphenhydramine as placebo, along with Motivational Enhancement Therapy and Taking Action therapy. They are not dependent on any other substance and are medically healthy. For psilocybin administration, patients lie on a couch with a sleep mask on, and therapists are present for all sessions.

With the study still blinded, researchers assessed Mystical Experience Questionnaire (MEQ) scores as a signal on whether patients were in the psilocybin group or not. Those with high MEQ scores had a significant reduction in percentage of heavy drinking days through week 12, Dr. Bogenschutz said.

Meanwhile, results were presented for the first 10 patients in a 40-patient study of psilocybin for cocaine treatment at the University of Alabama at Birmingham. Patients taking psilocybin have significantly more days of abstinence and significantly better scores on the Severity of Dependence Scale, compared with placebo, said Peter L. Hendricks, MD, of the department of anesthesiology at UAB. He said patients have reported no adverse effects of the treatment so far.

The mechanisms at work remain something of a puzzle, researchers said. Some patients report lower levels of depression and higher life satisfaction scores, which suggests that the treatment could lead to better coping ability.

Finally, research at Johns Hopkins University in Baltimore involving psilocybin administration to healthy volunteers has found that a high mystical experience score predicts feelings of meaningfulness, spiritual significance, and openness at 14 months and longer after it is administered, said Roland R. Griffiths, PhD, professor of psychiatry and behavioral science and of neuroscience at Johns Hopkins.

“Psilocybin, when administered to carefully screened and prepared volunteers, can occasion unique experiences that are judged to be personally meaningful and which are associated with enduring positive changes in mood, attitudes, and behavior,” he said. Neuroplasticity and changes in functional connections in the brain also could be playing a role, Dr. Bogenschutz said.

In his study of AUD, Dr. Bogenschutz said, occasionally patients do report unpleasant experiences with psilocybin administration. However, one patient called the sessions a “crash course in dealing with feelings of disappointment, regret, shame, and unworthiness.”

“There’s a lot of mystical-type content in these sessions, but there’s also a lot of other things going on,” he said, “that for many people seem to be equally important in terms of generating change.”

Dr. Bogenshutz reported funding from several sources, including the Heffter Research Institute, the Multidisciplinary Association for Psychedelic Studies, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism. Dr. Griffiths reported funding from Heffter, the Fetzer Institute, the Templeton Foundation, the Riverstyx Foundation, the Council of Spiritual Practices, and NIDA. Dr. Hendricks reported no relevant disclosures.

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