Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder (PAP-AUD)

This randomised, controlled clinical trial (n=128) aims to investigate whether a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with alcohol use disorder (AUD).

Led by the University of Calgary and collaborating with Johns Hopkins University, University of Maryland, and the Canadian Institutes of Health Research (CIHR), this study targets male and female patients aged 22-65 with a moderate to severe AUD diagnosis. Participants will be randomly assigned to either a high dose (25mg) or a low dose (1mg) psilocybin arm. All participants will undergo 5 sessions of MET, starting 24 hours post-dosing.

The primary outcome measure will be the reduction in heavy drinking assessed by the Time Line Follow Back (TLFB) at 1-, 4-, and 12-weeks post-dosing. Secondary measures include abstinence, biomarkers of alcohol consumption, alcohol cue reactivity, cognitive flexibility, depression, anxiety, quality of life, glutamate and GABA levels, and resting-state functional connectivity.

Eligible participants must meet DSM-5 AUD criteria of at least moderate severity, have had at least 5 heavy drinking days in the past 30 days, and desire to decrease alcohol consumption. Exclusion criteria include severe or moderate substance use disorder other than alcohol or nicotine in the past 6 months, certain psychiatric diagnoses, active suicidal ideation, pregnancy, and notable abnormalities in medical tests.

Recruitment is not yet underway, with an estimated study start date of January 2024 and completion date of May 2027. The study will take place at the University of Calgary in Alberta, Canada.

Trial Details

Data attribution