Psilocybin with psychotherapy reduced heavy drinking in those with alcohol use disorder
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Psilocybin-assisted psychotherapy significantly reduced the number of heavy drinking days in those with alcohol use disorder compared with placebo and psychotherapy, results of a clinical trial show.
Results of the study, which were initially revealed in a press conference from NYU Langone Health, were published in JAMA Psychiatry.
Charles Marmar, MD, chair of the department of psychiatry at NYU Langone Health, who was not an author on the study, called the study results a “major breakthrough” in the understanding and treatment of alcohol use disorder.
“The state of the art of treating alcohol use disorder remains very challenging,” Marmar said during a press conference on the study results. “Despite decades of research, there are few medication options, and the few we have are not highly effective over the long run and are not highly prescribed. There is an urgent need for novel medications.”
The double-blind, randomized clinical trial included 95 participants (mean age 46 years, 44.2% female) diagnosed with AUD who logged at least 4 heavy drinking days during 30 days before screening. The participants were given 12 weeks of manualized psychotherapy and assigned on a 1:1 basis to receive either psilocybin (n = 49) or placebo (n = 46) during two day-long medication sessions at weeks 4 and 8. Outcomes were assessed over the 32-week double-blind period after the first dose of study medication.
Ninety-three participants received at least one dose of study medication. Percentage of heavy drinking days during the 32-week double-blind period was 9.7% for the psilocybin group and 23.6% for the placebo group, a mean difference of 13.9%; (95% CI, 3.0–24.7; F1, 86=6.43). Mean daily alcohol consumption (number of standard drinks per day) was also lower in the psilocybin group. There were no serious adverse events among participants who received psilocybin.
“This was a trial of psilocybin-assisted treatment. We can’t make any statements on psilocybin’s therapeutic effects since psychotherapy was a component,” Michael Bogenschutz, MD, director of the NYU Langone Center for Psychedelic Medicine at NYU Langone Health and lead author of the study, said during the press conference.
After the study results were presented at the press conference, two participants, Jon Kostas and Paul Mavis, offered their perspectives on the course of the clinical trial.
Kostas, who revealed that his first experiences with Alcoholics Anonymous began at age 16 and who was 25 years old at the start of the study, was effusive in his praise, stating, “It saved my life. This could be a huge breakthrough for mental disorders, not just addiction.”
Mavis added that his experience with drinking was over 4 decades long before he realized in 2018 that he needed help. Over a period of 3 years prior to that, he related, he tracked his number of drinking days increasing but could never track how much he drank each day. “To say that it changed everything [is] an understatement. It’s like I never drank in my life,” Mavis added.
Bogenschutz said there is a plan for FDA approval, beginning with the pending launch of a larger clinical trial involving at least 15 sites and including approximately 200 participants, scheduled to commence in early 2023. The trial would take 2 to 3 years to complete, he said.
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