Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

NCT05855668 | Recruiting

• 1 other identifier: 2021/085
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Change in Number of Binge Drinking Days During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)

  Number of binge drinking days (≥ 4 drinks during a single day for females, ≥ 5 drinks during a single day for males)

  12 weeks

• Change in Cannabis Use Frequency During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)

  Number of days per week in which individuals used cannabis

  12 weeks

• Change in Average Drinks Per Day During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)

  Average number of drinks per day

  12 weeks

• Change in Amount of Cannabis Used Per Week (grams/week) During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)

  Amount of cannabis used per week

  12 weeks

• Change in Self-Reported Alcohol Craving During Treatment Assessed by the Penn Alcohol Craving Scale (PACS) (AUD Group)

  Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving)

  12 weeks

• Change in Self-Reported Cannabis Craving During Treatment Assessed by the Marijuana Craving Questionnaire-Short Form (MCQ) (CUD Group)

  Measures craving for marijuana (minimum score = 17; maximum score = 119; higher score indicates greater levels of craving)

  12 weeks

Secondary Outcomes (4)

• Retention in Treatment (AUD and CUD groups)

  12 weeks

• Change in Depressive Symptoms during Treatment Assessed Using the Patient Health Questionnaire-9 (PHQ-9) (AUD and CUD groups)

  12 weeks

• Change in Anxiety Symptoms During Treatment Using the Generalized Anxiety Disorder-7 (GAD-7) (AUD and CUD groups)

  12 weeks

• Change in Quality of Life During Treatment Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF) (AUD and CUD Groups)

  12 weeks

Study Arms (2)

Alcohol Use Disorder

OTHER

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.

Behavioral: CBT

Cannabis Use Disorder

OTHER

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

Behavioral: CBT

Interventions

CBT BEHAVIORAL

12 weeks of group CBT for AUD or CUD

Alcohol Use Disorder; Cannabis Use Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Able to communicate and provide informed consent in English.
• years of age or older.
• 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.
• Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group)
• 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)

You may not qualify if:

• Active suicidal ideation at time of assessment.
• Suicide attempt within the past month.
• 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).
• Enrollment in another study that conflicts with the procedures or scientific integrity of this study.
• Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• AFP Innovation Fund: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Matthew Sloan, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Xiao, MSc

CONTACT

416-535-8501; Kelly.Xiao@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start: November 10, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)