CARS: Cannabis and Alcohol Reduction Study (CARS)
Primary Purpose
Cannabis Use, Alcohol Use, Unspecified, Substance Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias
modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria:
- between the ages of 13 and 17
- be seeking treatment for either cannabis or alcohol use;
- report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous)
- have a caregiver willing to participate and provide consent.
Exclusion Criteria:
- being pregnant and/or breastfeeding
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group A: Treatment Group
Group B: Control Group
Arm Description
Outcomes
Primary Outcome Measures
Change in cannabis use as assessed by Timeline Followback
The TLFB is a calendar-assisted semi-structured interview that will be used to assess cannabis and alcohol use since the last assessment. The TLFB will assess the number of days a person used cannabis over the past 90 days compared to the 90 days prior to enrolling in this study.
Change in alcohol use as assessed by Timeline Followback
The TLFB is a calendar-assisted semi-structured interview that will be used to assess cannabis and alcohol use since the last assessment. The TLFB will assess the number of days a person consumed alcohol over the past 90 days compared to the 90 days prior to enrolling in this study.
Change in Cannabis Approach Bias (D-Score)
D scores will be calculated for each participant at baseline, posttest, and three-month follow-up. Participants' mean reaction times (RTs) during the approach cannabis trials will be subtracted from the mean avoid cannabis trial RTs. These scores are then divided by the SD across all cannabis trials. Positive scores indicate an approach bias for cannabis stimuli.
Change Cannabis Approach Bias (D-Score)
D scores will be calculated for each participant at baseline, posttest, and three-month follow-up. Participants' mean reaction times (RTs) during the approach alcohol trials will be subtracted from the mean avoid alcohol trial RTs. These scores are then divided by the SD across all alcohol trials. Positive scores indicate an approach bias for alcohol stimuli.
Secondary Outcome Measures
Full Information
NCT ID
NCT05486234
First Posted
August 1, 2022
Last Updated
January 26, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05486234
Brief Title
CARS: Cannabis and Alcohol Reduction Study
Acronym
CARS
Official Title
Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Youth will be recruited from the Center for Drug and Alcohol Programs (CDAP) Clinic in the Department of Psychiatry at MUSC. Follow-up assessments will be conducted at one- and three-months following treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Alcohol Use, Unspecified, Substance Use, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Treatment Group
Arm Type
Experimental
Arm Title
Group B: Control Group
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias
Intervention Description
Participants will undergo a baseline assessment before completing computerized tasks. During the baseline assessment, participants will be asked questions about alcohol and cannabis use. We will also ask questions about the way participants think about things, past life experiences related to substance use, and questions about how participants feel about reducing their substance use. Then, participants will complete a series computerized tasks where they will push and pull a joystick in response to images that are presented on a screen or where they will try to get a high score. During the computerized tasks, we will also be measuring brain activity using EEG. During the study, participants will also be asked to respond to questions about their health and behavior using an app on a smartphone or tablet using a secure program. Participants in the Treatment Group will then complete four sessions of the modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias.
Intervention Type
Behavioral
Intervention Name(s)
modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.
Intervention Description
Participants will undergo a baseline assessment before completing computerized tasks. During the baseline assessment, participants will be asked questions about alcohol and cannabis use. We will also ask questions about the way participants think about things, past life experiences related to substance use, and questions about how participants feel about reducing their substance use. Then, participants will complete a series computerized tasks where they will push and pull a joystick in response to images that are presented on a screen or where they will try to get a high score. During the computerized tasks, we will also be measuring brain activity using EEG. During the study, participants will also be asked to respond to questions about their health and behavior using an app on a smartphone or tablet using a secure program. Participants in the Control Group will then complete four sessions of an Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.
Primary Outcome Measure Information:
Title
Change in cannabis use as assessed by Timeline Followback
Description
The TLFB is a calendar-assisted semi-structured interview that will be used to assess cannabis and alcohol use since the last assessment. The TLFB will assess the number of days a person used cannabis over the past 90 days compared to the 90 days prior to enrolling in this study.
Time Frame
Baseline and Three-Month Follow-up
Title
Change in alcohol use as assessed by Timeline Followback
Description
The TLFB is a calendar-assisted semi-structured interview that will be used to assess cannabis and alcohol use since the last assessment. The TLFB will assess the number of days a person consumed alcohol over the past 90 days compared to the 90 days prior to enrolling in this study.
Time Frame
Baseline and Three-Month Follow-up
Title
Change in Cannabis Approach Bias (D-Score)
Description
D scores will be calculated for each participant at baseline, posttest, and three-month follow-up. Participants' mean reaction times (RTs) during the approach cannabis trials will be subtracted from the mean avoid cannabis trial RTs. These scores are then divided by the SD across all cannabis trials. Positive scores indicate an approach bias for cannabis stimuli.
Time Frame
Baseline, One-Week Follow-up, and Three-Month Follow-up
Title
Change Cannabis Approach Bias (D-Score)
Description
D scores will be calculated for each participant at baseline, posttest, and three-month follow-up. Participants' mean reaction times (RTs) during the approach alcohol trials will be subtracted from the mean avoid alcohol trial RTs. These scores are then divided by the SD across all alcohol trials. Positive scores indicate an approach bias for alcohol stimuli.
Time Frame
Baseline, One-Week Follow-up, and Three-Month Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 13 and 17
be seeking treatment for either cannabis or alcohol use;
report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous)
have a caregiver willing to participate and provide consent.
Exclusion Criteria:
- being pregnant and/or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Austin M Hahn, Ph.D.
Phone
854-444-9456
Email
hahna@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Hahn, Ph.D.
Phone
854-444-9456
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CARS: Cannabis and Alcohol Reduction Study
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