CARS: Cannabis and Alcohol Reduction Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias
BehavioralParticipants 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.
BehavioralParticipants 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Group B: Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Three-Month Follow-up2
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.
Time frame
Baseline and Three-Month Follow-up3
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.
Time frame
Baseline, One-Week Follow-up, and Three-Month Follow-up4
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.
Time frame
Baseline, One-Week Follow-up, and Three-Month Follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov