CARS: Cannabis and Alcohol Reduction Study

Substance Use Disorders Clinical Trial

— CARS  

Official title:

Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486234
• Other study ID #: 00106723
• Secondary ID: 1K23DA050800-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: Austin M Hahn, Ph.D.
• Phone: 854-444-9456
• Email: hahna[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Cannabis Use
• Marijuana Abuse
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Three-Month Follow-up
Primary	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.	Baseline and Three-Month Follow-up
Primary	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.	Baseline, One-Week Follow-up, and Three-Month Follow-up
Primary	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.	Baseline, One-Week Follow-up, and Three-Month Follow-up