UnknownPhase 2psilocybin
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
Sponsored by Clairvoyant Therapeutics
NCT ID
NCT05646303
Target Enrollment
128 participants
Start Date
2022-05-02
Est. Completion
2024-12-31
About This Study
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.
Conditions Studied
Interventions
- •Psilocybin
- •Placebo
Eligibility
Age:18 Years - 70 Years
Healthy Volunteers:No
View full 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.
Study Locations (12)
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
+2 more locations