Clinical trial NCT05646303: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Clairvoyant Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Optimapharm
First posted: 2022-12-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Reduction in the number of Heavy Drinking Days
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Sabi Mind
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Surrey
country: Canada
facility: Centre for Neurology Studies
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia, Department of Psychiatry, BRAIN Lab
state: British Columbia
city: Halifax
country: Canada
facility: Centricity Research
state: Nova Scotia
city: Hamilton
country: Canada
facility: MacAnxiety Research Centre
state: Ontario
city: Kingston
country: Canada
facility: Department of Psychiatry, Queen's University
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
city: Helsinki
country: Finland
facility: Research Center Oxidi Oy / Addiktum Oy
city: Kouvola
country: Finland
facility: A-Klinikka
city: Oulu
country: Finland
facility: Mentacare Oy
city: Turku
country: Finland
facility: Addiktum Oy
Study officials:
affiliation: Addiktum Oy
name: Hannu Alho, MD
role: PRINCIPAL_INVESTIGATOR
References: