Psilocybin in Alcohol Use Disorder With Comorbid Depression (PAD)

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of 25 mg psilocybin at three-week intervals compared to a control condition (1 mg psilocybin) on patients recently withdrawn from alcohol.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.

Topic Alcohol Use Disorder Depression Anxiety Addiction
Compound Psilocybin
Country France
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 January 2024
End date 31 July 2025
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 30
Sex All
Age 18- 99
Therapy Yes

Trial Details

About 40% of those with alcohol use disorder (AUD) also suffer from depression, which increases the risk of AUD relapse post-withdrawal. Psilocybin, a psychedelic treatment, shows promise in treating both depression and AUD. Its acute effects last around 6 hours and seem to aid in preventing alcohol relapse in recently detoxified individuals with depression. However, the acceptance of psilocybin therapy among eligible participants in France is uncertain due to evolving legal status and limited public perception data. Hence, evaluating its feasibility and acceptability in treating AUD and depression in hospitalized patients is crucial. This pilot study aims to assess the viability, acceptance, neural mechanisms, and initial efficacy of psilocybin alongside standard treatment in individuals with AUD and depressive symptoms post-withdrawal. The study proposes administering two 25 mg doses of psilocybin three weeks apart, compared to a control condition, alongside usual treatment, within 14 to 60 days post-alcohol consumption cessation.

Trial Number NCT06235411

Data attribution

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