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).

Conducted at Brugmann University Hospital, the study involves participants aged 21-64 undergoing a 4-week inpatient rehabilitation programme. The experimental group will receive a high dose of psilocybin (30 mg) while the control group will receive an active placebo dose of psilocybin, both within a brief standardized psychotherapeutic intervention.

The primary clinical outcome is the difference in the change in the percentage of heavy drinking days from baseline to four weeks post-hospital discharge. Safety and feasibility metrics will also be reported as primary outcomes. Secondary assessments include changes in drinking behaviour parameters up to six months post-hospital discharge, symptoms of depression, anxiety, trauma, global functioning, neuroplasticity, and psychological processes related to addiction.

Recruitment began in January 2024 and is expected to complete by December 2025.

Trial Details

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial

NCT Number NCT06160232

Data attribution

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