Marijuana Approach Bias Retraining and Neural Response in Youth (MJ-AAT)

This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.

Study Overview

• Status: Completed
• Conditions: Alcohol Approach/Avoidance Task; Sham Approach/Avoidance Task
• Intervention / Treatment: Behavioral: Marijuana Approach Avoidance Training

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between age 16 and 21
• having >50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (>1+/week for 52 weeks) at study entry.

Exclusion Criteria:

• not having a parent to consent (for those under age 18)
• prenatal alcohol (>2 drinks on an occasion or >4 drinks in a week) or any tobacco or illicit drug exposure
• premature birth (<34 weeks gestation), birth weight <5 lbs, or other gestational or perinatal complications
• history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
• current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
• use of any illicit substance (e.g., cocaine, methamphetamines) other than alcohol or marijuana > 100 times
• history of major neurological disorder or head trauma (with loss of consciousness >10 minutes)
• history of learning disability, pervasive developmental disorder, or other condition requiring special education
• current use of medications that affect cerebral blood flow
• non-correctable visual or hearing problems
• non-fluent in English
• MRI contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings)
• pregnant on day of scan
• intake of psychoactive medication as tested by urine drug screen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Approach Avoidance Training Condition; The AAT group will push away the joystick from marijuana pictures 90% of the trials and pull towards the marijuana pictures 10% of the trials.	Behavioral: Marijuana Approach Avoidance Training; Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.
Sham Comparator: Sham Condition; The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull.	Behavioral: Marijuana Approach Avoidance Training; Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in marijuana use from baseline through end of intervention	Assessing the change in marijuana use (as measured by number of days used marijuana X hits per day) from baseline to end of intervention.	From 60 days before intervention to end of 3 week intervention
Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task	Assessing the change in neural reactivity to marijuana cues before and after the intervention	3 weeks
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.		3 weeks
Change in short-term marijuana use from baseline to 1 month post-intervention	Assessing the short-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 month post-intervention.	From 60 days before intervention to 1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in long-term marijuana use from baseline to 1 year post-treatment	Assessing the long-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 year post-intervention.	From 60 days before intervention to 1 year post-intervention

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Lindsay M Squeglia, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse
• Other Study ID Numbers: 44583