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

A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05646303

Enrollment

128

Registered

2022-12-12

Start date

2022-05-02

Completion date

2024-12-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Brief 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.

Interventions

DRUGPsilocybin

Psilocybin and psychotherapy

DRUGPlacebo

Placebo and psychotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction in the number of Heavy Drinking Days	8 weeks	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).

Countries

Canada, Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026