Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

This double-blind, randomized, placebo-controlled Phase II trial (n=200) investigates the therapeutic neural mechanisms of psilocybin (30mg) in patients with alcohol use disorder (AUD).

Led by NYU Langone Health, the study aims to assess the effects of psilocybin on AUD through fMRI neural activation, alcohol use data, and self-report measures related to neural, emotional, and executive functions. Participants, aged 18 to 65, with a breath alcohol concentration ≤ 0.01%, will undergo either a single session of oral high-dose psilocybin (30 mg) or placebo, accompanied by three supportive therapy sessions.

Primary outcome measures include changes in the alcohol cue-induced BOLD signal in various brain regions, while secondary outcomes involve alcohol consumption patterns.

The study, scheduled from July 2024 to January 2029, aims to determine the potential of psilocybin-assisted treatment for AUD.

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Placebo
Country United States of America
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NYU Langone Health
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