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

Sponsor

Clairvoyant Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05646303

Collaborator

Optimapharm (Industry)

128

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder	Drug: Psilocybin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psilocybin 2 oral doses of 25mg psilocybin capsules	Drug: Psilocybin Psilocybin and psychotherapy
Placebo Comparator: Placebo 2 oral doses of placebo (microcrystalline cellulose) capsules	Drug: Placebo Placebo and psychotherapy

Arm

Intervention/Treatment

Experimental: Psilocybin

2 oral doses of 25mg psilocybin capsules

Drug: Psilocybin

Psilocybin and psychotherapy

Placebo Comparator: Placebo

2 oral doses of placebo (microcrystalline cellulose) capsules

Drug: Placebo

Placebo and psychotherapy

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sabi Mind	Calgary	Alberta	Canada	T3C 0J7
2	Okanagan Clinical Trials	Kelowna	British Columbia	Canada

Sponsors and Collaborators

Clairvoyant Therapeutics
Optimapharm

Investigators

Principal Investigator: Hannu Alho, MD, Addiktum Oy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clairvoyant Therapeutics

ClinicalTrials.gov Identifier:

NCT05646303

Other Study ID Numbers:

CLA PSY 201

First Posted:

Dec 12, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alcoholism

Alcohol Drinking

Psilocybin

Study Results

No Results Posted as of Dec 12, 2022