NCT05995769

Brief Summary

The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
17mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress62%
Mar 2024Oct 2027

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 7, 2024

Status Verified

August 1, 2023

Enrollment Period

3.5 years

First QC Date

August 9, 2023

Last Update Submit

May 6, 2024

Conditions

Alcohol Use DisorderAlcoholism

Outcome Measures

Primary Outcomes (1)

  • Heavy drinking

    Percent heavy drinking days (TLFB)

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

Secondary Outcomes (10)

  • Abstinence

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

  • Biomarkers of alcohol consumption

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

  • Alcohol cue reactivity

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

  • Cognitive flexibility

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

  • Depression

    Change from baseline to 1-, 4-, and 12-weeks post-dosing

  • +5 more secondary outcomes

Study Arms (2)

High Dose (25mg)

EXPERIMENTAL

PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Drug: Psilocybin

Low dose (1mg)

ACTIVE COMPARATOR

PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Drug: Psilocybin

Interventions

PsilocybinDRUG

Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing

Also known as: magic mushrooms, PEX010
High Dose (25mg)Low dose (1mg)

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-5 AUD criteria of at least moderate severity
  • Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
  • Desire to decrease alcohol consumption
  • Limited lifetime hallucinogen use

You may not qualify if:

  • Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
  • Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
  • Active suicidal ideation or serious attempt within past 3 years
  • Currently pregnant, nursing, or trying to become pregnant
  • Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

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

  • Leah Mayo, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin O'Grady

CONTACT

587-893-0257pactlab@ucalgary.ca

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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

March 20, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 7, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)