Clinical Trial

Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder

Not Yet Recruiting Phase 2

Summary

This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-12-18; most recent amendment 2026-06-12.

Trial Details

NCT Number	NCT07296094
Lead Sponsor	Brigham and Women's Hospital
Conditions	Alcohol Use Disorder
Enrollment	36 participants
Start Date	2026-08-15
Primary Completion	2029-12-01 (estimated)
Study Completion	2030-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-13