drugset / Trial / NCT07296094

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

NCT07296094

Phase 2 Not yet recruiting 36 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2026-06-15
Primary completion
2029-12-01
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 10 mg Oral
Subject Psilocybin Other / unclassified 30 mg Oral