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

Primary Purpose

Alcohol Use Disorder, Cannabis Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBT
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has been referred to and 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. Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group) 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: 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. Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

AUD

CUD

Arm 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.

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

Outcomes

Primary Outcome Measures

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
Change in Self-Reported Alcohol Craving During Treatment Assessed by the Penn Alcohol Craving Scale (PACS) (AUD Group)
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving)
Change in Self-Reported Cannabis Craving During Treatment Assessed by the Marijuana Craving Questionnaire-Short Form (MCQ) (CUD Group)
Measures craving for marijuana (minimum score = 17; maximum score = 119; higher score indicates greater levels of craving)

Secondary Outcome Measures

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)

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT05855668
Brief Title
Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment
Official Title
Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Innovation Fund of the Alternative Funding Plan for the Academic Health Sciences Centres of Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Cannabis Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AUD
Arm Type
Other
Arm 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.
Arm Title
CUD
Arm Type
Other
Arm Description
Participants will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD (group therapy).
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
12 weeks of group CBT for AUD or CUD
Primary Outcome Measure Information:
Title
Change in Number of Binge Drinking Days During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)
Description
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
Title
Change in Cannabis Use Frequency During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)
Description
Number of days per week in which individuals used cannabis
Time Frame
12 weeks
Title
Change in Average Drinks Per Day During Treatment Assessed by the Timeline Followback Interview (TLFB) (AUD Group)
Description
Average number of drinks per day
Time Frame
12 weeks
Title
Change in Amount of Cannabis Used Per Week (grams/week) During Treatment Assessed by the Timeline Followback Interview (TLFB) (CUD group)
Description
Amount of cannabis used per week
Time Frame
12 weeks
Title
Change in Self-Reported Alcohol Craving During Treatment Assessed by the Penn Alcohol Craving Scale (PACS) (AUD Group)
Description
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving)
Time Frame
12 weeks
Title
Change in Self-Reported Cannabis Craving During Treatment Assessed by the Marijuana Craving Questionnaire-Short Form (MCQ) (CUD Group)
Description
Measures craving for marijuana (minimum score = 17; maximum score = 119; higher score indicates greater levels of craving)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Retention in Treatment (AUD and CUD groups)
Description
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
Title
Change in Depressive Symptoms during Treatment Assessed Using the Patient Health Questionnaire-9 (PHQ-9) (AUD and CUD groups)
Description
Measures depressive symptoms (minimum score = 0; maximum score = 27; higher scores indicate higher levels of depressive symptoms)
Time Frame
12 weeks
Title
Change in Anxiety Symptoms During Treatment Using the Generalized Anxiety Disorder-7 (GAD-7) (AUD and CUD groups)
Description
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
Time Frame
12 weeks
Title
Change in Quality of Life During Treatment Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF) (AUD and CUD Groups)
Description
Measures quality of life (scores are transformed to 0-100; higher scores indicate higher quality of life)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has been referred to and 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. Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group) 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: 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. Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Xiao, BSc
Phone
416-535-8501
Ext
32447
Email
Kelly.Xiao@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Sloan, MD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Xiao, BSc
Phone
416-535-8501
Ext
32447
Email
kelly.xiao@camh.ca
First Name & Middle Initial & Last Name & Degree
Matthew Sloan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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