Psilocybin in Alcohol Use Disorder With Comorbid Depression (PAD)
Randomised, quadruple-blind, parallel pilot trial (n=30) testing two oral administrations of psilocybin (25 mg) versus inactive 1 mg control, given 3 weeks apart, for AUD with comorbid depression alongside usual care.
Details
This pilot parallel randomized trial will assess feasibility, acceptability, preliminary effectiveness and neural mechanisms of two psilocybin sessions (25 mg) versus inactive 1 mg control in recently withdrawn patients with severe alcohol use disorder and depressive symptoms.
Each treatment day includes preparation, a supervised dosing session (~6 hours) with music and accompaniment, and an integration session; outcomes include clinical measures of alcohol relapse and depression, EEG, blood immuno-inflammatory markers, stool microbiota and functional MRI.