Drug and alcohol dependence · 2026
Safety and efficacy of psilocybin-assisted therapy for alcohol use disorder: Open-label extension of a phase II randomized controlled trial.
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Pagni Broc A, Ross Stephen, Mennenga Sarah, Bhatt Snehal, Zeifman Richard J, Petridis Petros D, Carrithers Brennan M, Worth Lindsay, Podrebarac Samantha, Owens Lindsey T, O'Donnell Kelley, Roberts Daniel E, Kim Yuna, Bogenschutz Michael P
Аннотация
BACKGROUND: Psilocybin-assisted therapy (PAT) has shown promise for alcohol use disorder (AUD) in randomized controlled trials (RCTs). It remains unknown, however, whether patients derive additional benefit when psilocybin is administered open-label after completion of blinded treatment. Here, we report safety and efficacy outcomes from an open-label extension of a Phase II RCT of PAT for AUD (NCT02061293).
METHODS: Fifty-nine adults with AUD received a single open-label administration of psilocybin (25-40mg/70kg) accompanied by four hours of manualized therapy. During the preceding double-blind phase, 29 of these participants had received psilocybin (psilocybin-psilocybin group; PP) and 30 had received the active placebo diphenhydramine (diphenhydramine-psilocybin group; DP). Mixed-effects models for repeated measures evaluated alcohol consumption (percent heavy drinking days [PHDD], drinks per day [DpD], and percent drinking days [PDD]), alcohol craving, abstinence self-efficacy, and treatment readiness across a four-month follow-up.
RESULTS: Psilocybin was well tolerated, and no serious adverse events occurred. Among participants with higher drinking intensity at extension entry, decreases in PHDD, DpD, and PDD were observed at Month 1 but returned to entry levels thereafter. Craving, abstinence self-efficacy, and treatment readiness improved in both PP and DP groups one week after administration, with variable trajectories thereafter.
DISCUSSION: After completion of the double-blind trial, a single open-label psilocybin administration was associated with maintained remission among most participants who entered abstinent and with acute but largely transient reductions among those who were still drinking heavily. Whether the limited durability reflects the lower intensity of extension treatment, the relative treatment resistance of residual drinking, differences in motivation, or other design-related factors cannot be determined from these data.
CLINICAL TRIAL REGISTRATION: NCT02061293, A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence, https://clinicaltrials.gov/study/NCT02061293.
METHODS: Fifty-nine adults with AUD received a single open-label administration of psilocybin (25-40mg/70kg) accompanied by four hours of manualized therapy. During the preceding double-blind phase, 29 of these participants had received psilocybin (psilocybin-psilocybin group; PP) and 30 had received the active placebo diphenhydramine (diphenhydramine-psilocybin group; DP). Mixed-effects models for repeated measures evaluated alcohol consumption (percent heavy drinking days [PHDD], drinks per day [DpD], and percent drinking days [PDD]), alcohol craving, abstinence self-efficacy, and treatment readiness across a four-month follow-up.
RESULTS: Psilocybin was well tolerated, and no serious adverse events occurred. Among participants with higher drinking intensity at extension entry, decreases in PHDD, DpD, and PDD were observed at Month 1 but returned to entry levels thereafter. Craving, abstinence self-efficacy, and treatment readiness improved in both PP and DP groups one week after administration, with variable trajectories thereafter.
DISCUSSION: After completion of the double-blind trial, a single open-label psilocybin administration was associated with maintained remission among most participants who entered abstinent and with acute but largely transient reductions among those who were still drinking heavily. Whether the limited durability reflects the lower intensity of extension treatment, the relative treatment resistance of residual drinking, differences in motivation, or other design-related factors cannot be determined from these data.
CLINICAL TRIAL REGISTRATION: NCT02061293, A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence, https://clinicaltrials.gov/study/NCT02061293.