Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study

作者：Mathias Ebbesen Jensen, Dea Siggaard Stenbæk, Catharina Dragsted Messell, Emil Deleuran Poulsen, Tibor V. Varga, Patrick M. Fisher, Marie Katrine Klose Nielsen, Sys Stybe Johansen, Nora D. Volkow, Gitte M. Knudsen, Anders Fink‐Jensen · 发表于：Journal of Psychopharmacology · 年份：2025 · DOI：10.1177/02698811251319457 · 被引用次数：17 · 研究领域：Psychedelics and Drug Studies、Forensic Toxicology and Drug Analysis、Pain Management and Placebo Effect

Background: Psilocybin, a serotonin 2A receptor agonist with psychedelic properties, shows promise as a novel treatment for alcohol use disorder (AUD). While current studies involve two dosing sessions, the effects of a single dose have not been investigated. Aims: To investigate the pharmacokinetics, feasibility, safety and efficacy of single-dose psilocybin therapy in AUD. Methods: This open-label, single-group study investigated single-dose psilocybin therapy in 10 treatment-seeking adults (8 men and 2 women; median age 44 years) with severe AUD. The treatment involved two preparation sessions, a high-dose psilocybin session (25 mg) and two integration sessions. Pharmacokinetics were determined by noncompartmental analysis, and changes in alcohol consumption, craving and self-efficacy, were assessed using a linear mixed model. Results: Notable between-participant pharmacokinetic variations were observed, with peak plasma psilocin concentrations ranging from 14 to 59 µg/L. Alcohol consumption significantly decreased over the 12 weeks following psilocybin administration. Heavy drinking days were reduced by 37.5 percentage points (95% CI: −61.1 to −13.9, p = 0.005), and drinks per day decreased by 3.4 drinks (95% CI: −6.5 to −0.3, p = 0.03). This was corroborated by reports of rapid and sustained reductions in craving and increases in self-efficacy. Conclusions: Despite pharmacokinetic variations, a single 25 mg psilocybin dose was safe and effective in reducing alcohol consu...