CARS: Cannabis and Alcohol Reduction Study

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05486234
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
52
2
43

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias
  • Behavioral: modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A: Treatment Group

Behavioral: modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias
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.

Sham Comparator: Group B: Control Group

Behavioral: modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.
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.

Outcome Measures

Primary Outcome Measures

  1. Change in cannabis use as assessed by Timeline Followback [Baseline and Three-Month Follow-up]

    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.

  2. Change in alcohol use as assessed by Timeline Followback [Baseline and Three-Month Follow-up]

    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.

  3. Change in Cannabis Approach Bias (D-Score) [Baseline, One-Week Follow-up, and Three-Month Follow-up]

    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.

  4. Change Cannabis Approach Bias (D-Score) [Baseline, One-Week Follow-up, and Three-Month Follow-up]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Austin Hahn, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05486234
Other Study ID Numbers:
  • 00106723
  • 1K23DA050800-01A1
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022