Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder
Double-blind, randomised, placebo-controlled parallel study (n=90) testing a single 25 mg oral dose of psilocybin vs placebo, with a brief motivational interviewing intervention, in adults with MDD and co-occurring AUD; all participants receive a second unblinded 25 mg psilocybin dose after primary endpoints.
Details
This randomised, quadruple-blind, placebo-controlled Phase II trial will randomise 90 adults (21–65 years) with DSM-5 major depressive disorder and alcohol use disorder to a single 25 mg oral dose of psilocybin or placebo, paired with a brief motivational interviewing session for alcohol use.
Primary outcomes are change in clinician-rated GRID-HAMD for depression and alcohol consumption via TLFB; after primary endpoints all participants will be offered a second unblinded 25 mg psilocybin dose to test additive effects of two doses.