Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD

This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains.

NCT Number	NCT06349083
Lead Sponsor	NYU Langone Health Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol Use Disorder
Enrollment	200 participants
Start Date	2026-09-01
Primary Completion	2030-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-08-12