This randomised, double-blind trial (n=30) is set to examine the feasibility, acceptability, and preliminary effectiveness of psilocybin therapy (25mg, 2x) in treating alcohol use disorder (AUD) with comorbid depression after withdrawal, alongside standard treatment.
Led by Amandine Luquiens at Centre Hospitalier Universitaire de Nîmes, France, the study aims to assess the effects of two oral administrations of 25 mg psilocybin at three-week intervals compared to a control condition (1 mg psilocybin) on patients recently withdrawn from alcohol.
The primary outcome measure is the number of patients who complete both sessions. Secondary measures include recruitment, retainment rates, and changes in alcohol consumption, depression, anxiety, and quality of life.
Patients aged 18 or older with severe AUD and a Beck Depression Inventory II score of at least 14 are eligible. The study involves EEG assessments and qualitative analyses of the hallucinogenic experience.
Recruitment began in January 2024 and is expected to continue until July 2025.
Trial Details
Trial Number
Papers
Psilocybin in alcohol use disorder and comorbid depressive symptoms: Results from a feasibility randomized clinical trialThis double-blind, randomised controlled pilot study (n=30) found that psilocybin-assisted psychotherapy psilocybin (25mg; 2x; n=20) showed significantly higher abstinence rates at 12 weeks (55% vs 11%) compared to placebo (1mg; n=10) in patients with severe alcohol use disorder (AUD) and depression (MDD) who had recently completed detoxification.