Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial.
BMC Psychiatry January 26, 2024 Laetitia Vanderijst, Felix Hever, Anne Buot et al. 11 citations
A proposed clinical trial will test whether adding psilocybin-assisted therapy to inpatient rehabilitation for severe alcohol use disorder is feasible and effective. In a double-blind, randomized, placebo-controlled phase II trial, 62 participants aged 21–64 will receive either a high dose (30 mg) or an active placebo dose (5 mg) of psilocybin alongside a brief psychotherapy based on acceptance and commitment therapy. The main outcome is the difference in heavy drinking days from baseline to four weeks after hospital discharge. Secondary outcomes include drinking behavior up to six months, mental health symptoms, neuroplasticity, and cognitive mechanisms. The trial is registered as EudraCT 2022-002369-14 and NCT06160232.