Recruiting

Observational Study

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05855668

Conditions

Alcohol Use Disorder

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CBT

Study Details

Brief summary:

This 2-arm study will recruit participants with 1) alcohol use disorder and 2) cannabis use disorder for a 12-week cognitive behavioral therapy, following a thorough baseline assessments on executive function, incentive salience, and negative emotionality.

Conditions

Alcohol Use Disorder

Cannabis Use Disorder

Study ID

NCT05855668

Start date

Nov 10, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient has been referred to or intends to participate in either the AUD or CUD Integrated Care Pathway (and is therefore willing to participate in group psychotherapy).
2. Able to communicate and provide informed consent in English.
3. 18 years of age or older.
4. Willing and able to safely abstain from substances (other than nicotine or tobacco products), including alcohol and cannabis, for 12 hours prior to the eligibility and task-based assessments.
5. Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group)
6. Meets criteria for risky drinking, defined as > 10 drinks per week for females and > 15 drinks per week for males on average over the past 30 days (AUD group) or daily or near-daily cannabis use over the past 30 days, defined as ≥ 4 days of cannabis use per week on average (CUD group)

Exclusion Criteria:

1. Active suicidal ideation at time of assessment.
2. Suicide attempt within the past month.
3. Unstable psychiatric or medical status (e.g., acute psychosis or mania) or unstable use of another substance that may interfere with participation in groups (e.g. active fentanyl use).
4. Enrollment in another study that conflicts with the procedures or scientific integrity of this study.
5. Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Alcohol Use Disorder

Participants will be treated with 12 weeks of CBT for AUD (group therapy) and have the option to receive evidence-based pharmacotherapy for AUD guided by a pharmacotherapy algorithm.

other: Cannabis Use Disorder

Participants will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD (group therapy).

Interventions

CBT

12 weeks of group CBT for AUD or CUD

Primary outcome measure

  • Change in Number of Binge Drinking Days During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group) [ Time Frame: 12 weeks ]
  • Change in Cannabis Use Frequency During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group) [ Time Frame: 12 weeks ]
  • Change in Average Drinks Per Day During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group) [ Time Frame: 12 weeks ]
  • Change in Amount of Cannabis Used Per Week (grams/week) During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group) [ Time Frame: 12 weeks ]
  • Change in Self-Reported Alcohol Craving During Treatment Assessed by the Penn Alcohol Craving Scale (PACS) (AUD Group) [ Time Frame: 12 weeks ]
  • Change in Self-Reported Cannabis Craving During Treatment Assessed by the Marijuana Craving Questionnaire-Short Form (MCQ) (CUD Group) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

Principal Investigator:

Matthew Sloan, MD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-03-20.