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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre for Addiction and Mental Health

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • CBT

    Behavioral

    12 weeks of group CBT for AUD or CUD

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Alcohol Use DisorderOther 1 intervention
Group B: Cannabis Use DisorderOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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

Average number of drinks per day

Time frame
12 weeks
4

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

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks
2

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)

Time frame
12 weeks
3

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)

Time frame
12 weeks
4

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)

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre for Addiction and Mental Health

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

AFP Innovation Fund

Collaborator