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BONITA SPRINGS, FLA. – 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.
BONITA SPRINGS, FLA. – 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.
BONITA SPRINGS, FLA. – 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.
REPORTING FROM AAAP 2018