Safety and Efficacy of Psilocybin-Assisted Therapy for Alcohol Use Disorder: Open-Label Extension of a Phase II Randomized Controlled Trial
PsyArXiv March 26, 2026 Broc A Pagni, Stephen Ross, Sarah Mennenga et al. preprint
An 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.