Safety and Efficacy of Psilocybin-Assisted Therapy for Alcohol Use Disorder: Open-Label Extension of a Phase II Randomized Controlled Trial
Broc A. Pagni, Stephen Ross, Sarah E. Mennenga, Snehal Bhatt, Richard J. Zeifman, Petros Petridis, Brennan M. Carrithers, Lindsay Worth, Samantha K. Podrebarac, Lindsey T. Owens, Kelley C O'Donnell, Daniel E. Roberts, Yuna Kim, Michael P. Bogenschutz
PsyArXiv March 26, 2026 preprint DOI: 10.31234/osf.io/7xfek_v1 (opens in new tab)
Summary
AI-generated from the abstractAn open-label extension of a Phase II randomized controlled trial examined the safety and efficacy of psilocybin-assisted therapy for alcohol use disorder. Participants who had received either psilocybin or placebo in the main trial were offered two open-label psilocybin sessions. The treatment was well tolerated, with no serious adverse events attributed to psilocybin. Heavy drinking days decreased substantially from baseline, and the reduction was sustained through the 32-week follow-up. The findings suggest that psilocybin-assisted therapy may produce durable reductions in alcohol consumption among individuals with alcohol use disorder.
Study at a glance
| Characteristics | Open-label extension of a Phase II randomized controlled trial |
|---|---|
| Population | Individuals with alcohol use disorder |
| Intervention | Psilocybin-assisted therapy |
| Key finding | Psilocybin-assisted therapy was safe and associated with sustained reductions in heavy drinking days over 32 weeks in individuals with alcohol use disorder. |
Abstract
Safety and Efficacy of Psilocybin-Assisted Therapy for Alcohol Use Disorder: Open-Label Extension of a Phase II Randomized Controlled Trial