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)

Clairvoyant Therapeutics12 sites in 2 countries128 target enrollmentMay 2, 2022

ConditionsAlcohol Use Disorder

InterventionsPsilocybin Placebo

DrugsPsilocybin Placebo

Overview

Phase: Phase 2
Intervention: Psilocybin
Conditions: Alcohol Use Disorder
Sponsor: Clairvoyant Therapeutics
Enrollment: 128
Locations: 12
Primary Endpoint: Reduction in the number of Heavy Drinking Days
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2, 2022

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Clairvoyant Therapeutics

Responsible Party

Sponsor

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.

Arms & Interventions

Psilocybin

2 oral doses of 25mg psilocybin capsules

Intervention: Psilocybin

Placebo

2 oral doses of placebo (microcrystalline cellulose) capsules

Intervention: Placebo

Outcomes

Primary Outcomes

Reduction in the number of Heavy Drinking Days

Time Frame: 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).