Recruiting
Phase 2

Psilocybin

Sponsor:

University of Calgary

Code:

NCT05995769

Conditions

Alcohol Use Disorder

Alcoholism

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Study Details

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).

Conditions

Alcohol Use Disorder

Alcoholism

Study ID

NCT05995769

Start date

Mar 20, 2024

Status verified date

Aug, 2023

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High Dose (25mg)

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

active comparator: Low dose (1mg)

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

Interventions

Psilocybin

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

Primary outcome measure

  • Heavy drinking [ Time Frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing ]

Central Contacts and Locations

Central contacts

Kaitlin O'Grady

587-893-0257pactlab@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

More Information

Sponsor

University of Calgary

Last update posted

May 7, 2024

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-05-07.