Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial

This randomized, double-blinded, placebo-controlled clinical trial (n=100) will investigate the potential of a single administration of psilocybin to reduce alcohol intake in patients with alcohol use disorder (AUD).

The trial, sponsored by the Psychiatric Centre Copenhagen and supported by The Novo Nordic Foundation, The Lundbeck Foundation, and The Ivan Nielsen Foundation, aims to evaluate the effects of psilocybin on heavy drinking days over a 12-week period. Participants, aged 20-70 years with a body weight of 60-95 kg, must be diagnosed with alcohol use disorder (AUD) according to DSM-5 criteria and alcohol dependence according to ICD-10, with an AUDIT score ≥ 15 and at least 5 heavy drinking days in the past 28 days.

Exclusion criteria include a history of psychotic spectrum disorders or bipolar disorder, suicidal ideation, severe neurological diseases, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension, recent pharmacotherapy for AUD or serotonergic medication, and active substance use disorder, among others.

The primary endpoint is the percentage of heavy drinking days during the last 28 days, measured via the Timeline Followback method. Secondary endpoints include total alcohol consumption, percentage of days without alcohol consumption, various psychological assessment scores, biomarkers, and neuroimaging outcomes.

The trial, conducted at a single site in Copenhagen, Denmark, has received authorisation from the Danish Health Authority and a favourable opinion from the Ethics Committee. It is anticipated to end in the third quarter of 2024.

Topic Alcohol Use Disorder Addiction
Compound Psilocybin Placebo
Country Denmark
Visit trial
Status Active, not recruiting
Results Published No
Start date 16 December 2020
End date 30 September 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 100
Sex All
Age 20- 70
Therapy Yes

Trial Details

This trial (n=100) investigates whether a single dose of psilocybin can reduce alcohol intake in patients with alcohol use disorder. Led by the Psychiatric Centre Copenhagen and supported by several foundations, it aims to assess the impact of psilocybin on heavy drinking days over 12 weeks. Participants, aged 20-70, must meet specific criteria, including a diagnosis of alcohol use disorder and a history of heavy drinking. The study excludes individuals with certain medical conditions or recent medication use. Primary outcomes include the percentage of heavy drinking days, with secondary measures covering various psychological assessments and biomarkers. The trial, conducted in Copenhagen, Denmark, is expected to conclude in 2024.

NCT Number 2020-000829-55

Data attribution

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