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

NCT ID: NCT05855668

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Use Disorder Cannabis Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

CBT

Intervention Type BEHAVIORAL

12 weeks of group CBT for AUD or CUD

Cannabis Use Disorder

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

Group Type OTHER

CBT

Intervention Type BEHAVIORAL

12 weeks of group CBT for AUD or CUD

Interventions

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CBT

12 weeks of group CBT for AUD or CUD

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

AFP Innovation Fund

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Sloan, MD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kelly Xiao, MSc

Role: CONTACT

416-535-8501 ext. 32447

Facility Contacts

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Kelly Xiao, BSc

Role: primary

416-535-8501 ext. 32447

Other Identifiers

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2021/085

Identifier Type: -

Identifier Source: org_study_id

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