Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
This double-blind, randomized, placebo-controlled trial (n=62) aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy (30mg) as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder (AUD).
Details
Double-blind, randomized, placebo-controlled parallel-group Phase II trial of 62 participants (21–64 years) undergoing a 4-week inpatient rehabilitation programme, comparing a single 30 mg dose of psilocybin plus standardised psychotherapeutic support versus a very low-dose active placebo psilocybin.
Primary outcome is between-group change in percentage of heavy drinking days from baseline to four weeks post-discharge; key secondary outcomes include drinking behaviour to six months, PEth biomarker, mood/anxiety/trauma symptoms, global functioning, and neurocognitive and neuroplasticity measures.