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Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
Sponsor: Brigham and Women's Hospital
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).
Official title: Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder: A Double-Blind, Dose-Comparison Concurrent Control Randomized Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-05-01
Completion Date
2030-02
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Psilocybin
Psilocybin is administered in oral capsule form during two dosing sessions held four weeks apart. Each session occurs in a controlled clinical environment with continuous monitoring by trained study therapists. Participants receive a standardized psychotherapy protocol that includes preparatory sessions before dosing and integration sessions afterward. The randomized dosing schedule includes either 10 mg with optional escalation to 15 mg or 30 mg with optional escalation to 40 mg for the second session. All participants also receive support from a peer recovery coach and are offered ongoing outpatient addiction treatment throughout the study period.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States