drugset / Trial / NCT06160232
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
Timeline
- Start
- 2024-02-15
- Primary completion
- 2025-12-15
- Completion
- 2026-06-15
Publications
- Background Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O'Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Oct 1;79(10):953-962. doi: 10.1001/jamapsychiatry.2022.2096.
- Vanderijst L, Hever F, Buot A, Daure C, Benoit J, Hanak C, Veeser J, Morgieve M, Campanella S, Kornreich C, Mallet L, Leys C, Noel X. Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial. BMC Psychiatry. 2024 Jan 26;24(1):77. doi: 10.1186/s12888-024-05502-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Psilocybin | Other / unclassified | 30 mg | — |