Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial
This randomized, double-blinded, placebo-controlled trial (n=100) tests whether a single 25 mg oral psilocybin capsule reduces heavy drinking days in patients with alcohol use disorder.
Details
Randomised, double-blind, placebo-controlled, single-site Phase II trial in Denmark evaluating a single 25 mg oral dose of psilocybin (PEX010) versus placebo in patients with alcohol use disorder (n=100).
Primary outcome is percentage of heavy drinking days over the last 28 days at 12-week follow-up; secondary outcomes include total alcohol consumption, abstinent days, craving scales, liver biomarkers, pharmacokinetics of psilocin, and fMRI measures.
The trial includes comprehensive safety monitoring, assessment of the acute psychedelic experience with validated questionnaires, and exploration of brain network changes related to treatment response.