A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)

Multicentre, randomised, double-blind, parallel-group Phase II study comparing a single 25 mg oral psilocybin capsule plus psychotherapy to matching placebo in adults with moderate to severe AUD; primary outcome is monthly number of heavy drinking days over the 8-week treatment period.

Secondary endpoints include total alcohol consumption, proportion with no heavy drinking days, WHO risk level reductions, DSM-5 score change, safety outcomes (AEs/SAEs, labs, vitals, ECG) and measures of the psychedelic experience (5D-ASC, MEQ). The trial was authorised by Finland (Fimea) but was prematurely ended on 2024-12-10.