Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
Alcohol Use Disorder
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria: Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator. Expressed a wish to reduce or stop alcohol consumption. Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology. Exclusion Criteria: Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders. Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session. History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.
Sites / Locations
- Sabi MindRecruiting
- Okanagan Clinical TrialsRecruiting
- Centre for Neurology StudiesRecruiting
- University of British Columbia, Department of Psychiatry, BRAIN LabRecruiting
- Centricity ResearchRecruiting
- MacAnxiety Research CentreRecruiting
- Department of Psychiatry, Queen's UniversityRecruiting
- Centre for Addiction and Mental HealthRecruiting
- Research Center Oxidi Oy / Addiktum OyRecruiting
- Mentacare OyRecruiting
- Addiktum OyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Psilocybin
Placebo
2 oral doses of 25mg psilocybin capsules
2 oral doses of placebo (microcrystalline cellulose) capsules