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

Center for Addiction and Mental Health (CAMH)

Status: Enrolling

Conditions: Cannabis Use Disorder; Alcohol Use Disorder

Treatments: Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05855668

2021/085

Details and patient eligibility

About

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.

Full description

Although effective evidence-based interventions have been developed for alcohol and cannabis use disorders, it is still unclear which individuals respond best to treatment. A recent model known as the Addictions Neuroclinical Assessment (ANA) proposes that assessing for differences in three neurofunctional domains (executive function, incentive salience, and negative emotionality) could allow for a stronger neuroscience-based framework for understanding heterogeneity in response to addiction treatments but this has never been tested prospectively. In this study, we will recruit two groups: (1) participants with alcohol use disorder (AUD) and (2) participants with cannabis use disorder (CUD). Participants will undergo thorough baseline assessments of each of the three ANA domains prior to evidence-based treatment for their respective disorders. Individuals with AUD will be treated with 12 weeks of cognitive behavioral therapy (CBT) for AUD plus optional pharmacotherapy guided by a pharmacotherapy algorithm. Individuals with CUD will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD. The primary objective of the study is to assess whether baseline ANA measures are associated with changes in drug consumption and craving over treatment.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Alcohol Use Disorder

Other group

Description:

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.

Treatment:

Behavioral: CBT

Cannabis Use Disorder

Other group

Description:

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

Treatment:

Behavioral: CBT