About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
18 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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
CBT
Behavioral12 weeks of group CBT for AUD or CUD
Treatment groups
Trial outcomes
Primary outcomes
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)
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
Change in Average Drinks Per Day During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)
Average number of drinks per day
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
Secondary outcomes
Retention in Treatment (AUD and CUD groups)
Proportion of study participants that complete the treatment. Individuals who miss their first 2 sessions of therapy or miss more than 3 sessions of psychotherapy (i.e. ≥ 4 sessions or 33% of sessions) will be considered to have dropped out of treatment and will be discharged from the program. Participants who do not show up to any groups will not be included in this or other analyses.
Change in Depressive Symptoms during Treatment Assessed Using the Patient Health Questionnaire-9 (PHQ-9) (AUD and CUD groups)
Measures depressive symptoms (minimum score = 0; maximum score = 27; higher scores indicate higher levels of depressive symptoms)
Change in Anxiety Symptoms During Treatment Using the Generalized Anxiety Disorder-7 (GAD-7) (AUD and CUD groups)
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
Change in Quality of Life During Treatment Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF) (AUD and CUD Groups)
Measures quality of life (scores are transformed to 0-100; higher scores indicate higher quality of life)
Sponsors and contacts
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Centre for Addiction and Mental Health
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
AFP Innovation Fund
Collaborator