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Unknown statusPhase 2

Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

NCT05646303 · Clairvoyant Therapeutics

Closed to entry
Status
Not accepting participants
Phase 2
Phase
128
Target enrolment
12
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Reduction in the number of Heavy Drinking Days

    Measured over 8 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

12 study sites

FacilityCityRegionCountry
Sabi MindCalgaryAlbertaCanada
Okanagan Clinical TrialsKelownaBritish ColumbiaCanada
Centre for Neurology StudiesSurreyBritish ColumbiaCanada
University of British Columbia, Department of Psychiatry, BRAIN LabVancouverBritish ColumbiaCanada
Centricity ResearchHalifaxNova ScotiaCanada
MacAnxiety Research CentreHamiltonOntarioCanada
Department of Psychiatry, Queen's UniversityKingstonOntarioCanada
Centre for Addiction and Mental HealthTorontoOntarioCanada
Research Center Oxidi Oy / Addiktum OyHelsinkiFinland
A-KlinikkaKouvolaFinland
Mentacare OyOuluFinland
Addiktum OyTurkuFinland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05646303 on ClinicalTrials.gov →

Last updated in the registry 2024-08-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits