The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are: * Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? * Is treatment with psilocybin and therapy safe for participants? Participants will * Attend 13 study visits * Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo * Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Psilocybin and psychotherapy
Placebo and psychotherapy
Sabi Mind
Calgary, Alberta, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Centre for Neurology Studies
Surrey, British Columbia, Canada
University of British Columbia, Department of Psychiatry, BRAIN Lab
Vancouver, British Columbia, Canada
Centricity Research
Halifax, Nova Scotia, Canada
MacAnxiety Research Centre
Hamilton, Ontario, Canada
Department of Psychiatry, Queen's University
Kingston, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Research Center Oxidi Oy / Addiktum Oy
Helsinki, Finland
A-Klinikka
Kouvola, Finland
...and 2 more locations
Reduction in the number of Heavy Drinking Days
Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female).
Time frame: 8 weeks
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