Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
Alcohol Use DisorderThe 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.
null
Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
18 to 70
Critères de participation
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.
Lieu de l'étude
Centre for Neurology Studies
Centre for Neurology StudiesSurrey, British Columbia
Canada
Contactez l'équipe d'étude
Department of Psychiatry, Queen's University
Department of Psychiatry, Queen's UniversityKingston, Ontario
Canada
Contactez l'équipe d'étude
Okanagan Clinical Trials
Okanagan Clinical TrialsKelowna, British Columbia
Canada
Contactez l'équipe d'étude
MacAnxiety Research Centre
MacAnxiety Research CentreHamilton, Ontario
Canada
Contactez l'équipe d'étude
University of British Columbia, Department of Psychiatry, BRAIN Lab
University of British Columbia, Department of Psychiatry, BRAIN LabVancouver, British Columbia
Canada
Contactez l'équipe d'étude
Centre for Addiction and Mental Health
Centre for Addiction and Mental HealthToronto, Ontario
Canada
Contactez l'équipe d'étude
Sabi Mind
Sabi MindCalgary, Alberta
Canada
Contactez l'équipe d'étude
Centricity Research
Centricity ResearchHalifax, Nova Scotia
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Clairvoyant Therapeutics
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05646303