NCT05646303

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2022

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 15, 2024

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

December 2, 2022

Last Update Submit

August 14, 2024

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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).

    8 weeks

Study Arms (2)

Psilocybin

EXPERIMENTAL

2 oral doses of 25mg psilocybin capsules

Drug: Psilocybin

Placebo

PLACEBO COMPARATOR

2 oral doses of placebo (microcrystalline cellulose) capsules

Drug: Placebo

Interventions

PsilocybinDRUG

Psilocybin and psychotherapy

Psilocybin
PlaceboDRUG

Placebo and psychotherapy

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Sabi Mind

Calgary, Alberta, T3C 0J7, Canada

Location

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

Location

Centre for Neurology Studies

Surrey, British Columbia, Canada

Location

University of British Columbia, Department of Psychiatry, BRAIN Lab

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Centricity Research

Halifax, Nova Scotia, B3S 1N2, Canada

Location

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

Department of Psychiatry, Queen's University

Kingston, Ontario, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Research Center Oxidi Oy / Addiktum Oy

Helsinki, Finland

Location

A-Klinikka

Kouvola, 45100, Finland

Location

Mentacare Oy

Oulu, Finland

Location

Addiktum Oy

Turku, Finland

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines

Study Officials

  • Hannu Alho, MD

    Addiktum Oy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2022

First Posted

December 12, 2022

Study Start

May 2, 2022

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

August 15, 2024

Record last verified: 2023-09

Locations

CA(8)FI(4)