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

Last updated: February 15, 2024
Sponsor: Centre for Addiction and Mental Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Use Disorder

Alcohol Dependence

Addictions

Treatment

CBT

Clinical Study ID

NCT05855668
2021/085
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient has been referred to or intends to participate in either the AUD or CUDIntegrated Care Pathway (and is therefore willing to participate in grouppsychotherapy).
  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 tobaccoproducts), including alcohol and cannabis, for 12 hours prior to the eligibility andtask-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 ornear-daily cannabis use over the past 30 days, defined as ≥ 4 days of cannabis use perweek on average (CUD group)

Exclusion

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 unstableuse of another substance that may interfere with participation in groups (e.g. activefentanyl use).
  4. Enrollment in another study that conflicts with the procedures or scientific integrityof this study.
  5. Individuals planning to be out of the province for a substantial amount of time duringthe treatment period will not be permitted to enroll.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: CBT
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Centre for Addiction and Mental Health

    Toronto, Ontario M6J 1H4
    Canada

    Active - Recruiting

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