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

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Psilocybin
Placebo
Sponsored by
Clairvoyant Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sabi MindRecruiting
  • Okanagan Clinical TrialsRecruiting
  • Centre for Neurology StudiesRecruiting
  • University of British Columbia, Department of Psychiatry, BRAIN LabRecruiting
  • Centricity ResearchRecruiting
  • MacAnxiety Research CentreRecruiting
  • Department of Psychiatry, Queen's UniversityRecruiting
  • Centre for Addiction and Mental HealthRecruiting
  • Research Center Oxidi Oy / Addiktum OyRecruiting
  • Mentacare OyRecruiting
  • Addiktum OyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Psilocybin

Placebo

Arm Description

2 oral doses of 25mg psilocybin capsules

2 oral doses of placebo (microcrystalline cellulose) capsules

Outcomes

Primary Outcome Measures

Reduction in the number of Heavy Drinking Days
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).

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
September 8, 2023
Sponsor
Clairvoyant Therapeutics
Collaborators
Optimapharm
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1. Study Identification

Unique Protocol Identification Number
NCT05646303
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clairvoyant Therapeutics
Collaborators
Optimapharm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
2 oral doses of 25mg psilocybin capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 oral doses of placebo (microcrystalline cellulose) capsules
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Psilocybin and psychotherapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo and psychotherapy
Primary Outcome Measure Information:
Title
Reduction in the number of Heavy Drinking Days
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Yan
Email
hello@clairvoyantrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu Alho, MD
Organizational Affiliation
Addiktum Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sabi Mind
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3C 0J7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillippe Lucas
Email
philippe@sabimind.com
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Klukas, B.A.
Phone
250-862-8141
Email
ethan@oktrials.ca
Facility Name
Centre for Neurology Studies
City
Surrey
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Email
CNSNeuroStudies@gmail.com
Facility Name
University of British Columbia, Department of Psychiatry, BRAIN Lab
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Email
brainlab.clairvoyant@ubc.ca
First Name & Middle Initial & Last Name & Degree
Christian Schutz, MD, PhD, MPH
Facility Name
Centricity Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Rushton
Email
studies@centricityresearch.com
Facility Name
MacAnxiety Research Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Patterson
Phone
289 396 4242
Email
bpatter@mcmaster.ca
Facility Name
Department of Psychiatry, Queen's University
City
Kingston
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Soares, MD, PhD, MBA
Email
Claudio.Soares@kingstonhsc.ca
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dea Gjomema
Phone
416-979-6933
Email
Dea.Gjomema@camh.ca
Facility Name
Research Center Oxidi Oy / Addiktum Oy
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannu Alho, MD, PhD
Facility Name
Mentacare Oy
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markku Timonen
Facility Name
Addiktum Oy
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antti Mikkonen

12. IPD Sharing Statement

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

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