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

• ClinicalTrials.gov Identifier: NCT05646303
• Recruitment Status: Recruiting
• First Posted: December 12, 2022
• Last Update Posted: November 3, 2023
• Sponsor: Clairvoyant Therapeutics
• Collaborator: Optimapharm
• Information provided by (Responsible Party): Clairvoyant Therapeutics

Tracking Information

• First Submitted Date: December 2, 2022
• First Posted Date: December 12, 2022
• Last Update Posted Date: November 3, 2023
• Actual Study Start Date: May 2, 2022
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 2, 2022)

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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
• 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)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alcohol Use Disorder

Intervention

• Drug: Psilocybin
  Psilocybin and psychotherapy
• Drug: Placebo
  Placebo and psychotherapy

Study Arms

• Experimental: Psilocybin
  2 oral doses of 25mg psilocybin capsules
  Intervention: Drug: Psilocybin
• Placebo Comparator: Placebo
  2 oral doses of placebo (microcrystalline cellulose) capsules
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 2, 2022): 128
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Teresa Yan; hello@clairvoyantrx.com

• Listed Location Countries: Canada, Finland

Administrative Information

• NCT Number: NCT05646303
• Other Study ID Numbers: CLA PSY 201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Clairvoyant Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Clairvoyant Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Optimapharm

Investigators

• Principal Investigator: Hannu Alho, MD; Addiktum Oy

• PRS Account: Clairvoyant Therapeutics
• Verification Date: September 2023