Psilocybin Decreases Heavy Alcohol Use Days in Patients with AUD

Michael P. Bogenschutz, MD

A new study shows the benefit of using psilocybin as a treatment for patients with alcohol use disorder (AUD).

A team, led by Michael P. Bogenschutz, MD, Department of Psychiatry, New York University Langone Center for Psychedelic Medicine, New York University Grossman School of Medicine, evaluated whether 2 administrations of high-dose psilocybin improve the percentage of heavy drinking days for patients with AUD undergoing psychotherapy compared to active placebo medication and psychotherapy.

Psilocybins

Research in recent years using classic psychedelic medications as a treatment for alcohol use disorder has been promising, but the efficacy of psilocybin is unknown.

In the double-blind randomized clinical trial, the investigators examined 95 patients who were treated with 12 weeks of manualized psychotherapy and either psilocybin (n = 49) or diphenhydramine (n = 46) during a 2-day-long medication session at week 4 and 8 at 2 academic centers in the US between March 12, 2014 and March 19, 2020. The patients were aged 25-65 years with a DSM-IV diagnosis of alcohol dependence and at least 4 heavy drinking days during the 30 days prior to screening.

The mean age of the patient population was 46 years.

Patients with major psychiatric and drug use disorders, hallucinogen use, medical conditions that contraindicated the study medications, use of exclusionary medications, and current treatment for AUD were excluded.

Outcome

The investigators sought main outcomes of the percentage of heavy drinking days, assessed using a timeline followback interview, contrasted between groups over the study period following the first administration of medication using multivariate repeated-measures analysis of variance.

The investigators assessed outcomes over the 32-week double-blind period following the first dose of medication.

The patients were treated with either 25 per 70 kg of psilocybin or 50 mg diphenhydramine during the first session and 25-40 mg per 70 kg psilocybin or 50-100 mg diphenhydramine for the second session.Psychotherapy for both groups included motivational enhancement therapy and cognitive behavioral therapy.

Of the 95 patients initially included in the study, 93 received at least 1 dose of study medication and were included in the final analysis.

Drinking Results

The percentage of heavy drinking days during the double-blind period was 9.7% in the treatment group, compared to 23.6% in the diphenhydramine group, equating to a mean difference of 13.9% (95% CI, 3.0–24.7; F1,86 = 6.43; P = .01).

The mean daily alcohol consumption was also lower in the psilocybin group compared to the placebo group.

For safety, there were no serious adverse events in the psilocybin group.

“Psilocybin administered in combination with psychotherapy produced robust decreases in percentage of heavy drinking days over and above those produced by active placebo and psychotherapy,” the authors wrote. “These results provide support for further study of psilocybin-assisted treatment for AUD.”

The study, “Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder,” was published online in JAMA Psychiatry.