Psilocybin for alcohol use disorder: Rationale and design considerations for a randomized controlled trial.
Contemporary clinical trials December 1, 2022 Kelley C O'Donnell, Sarah E Mennenga, Lindsey T Owens et al. 24 citations
Classic psychedelics like psilocybin may help people change their behavior in substance use disorders. This paper describes the protocol for a multi-site, double-blind, randomized controlled trial that tested psilocybin-assisted psychotherapy in 96 alcohol-dependent volunteers. Participants received either psilocybin or an active placebo (diphenhydramine) during two dosing sessions, alongside a structured 12-week psychotherapy platform. The primary outcome was the proportion of heavy drinking days over 32 weeks after the first dose. Secondary outcomes included safety, abstinence, craving, and self-efficacy. The primary results are reported elsewhere; this paper focuses on the rationale and design decisions.