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Completed

NCT Number: NCT02723149

Marijuana Approach Bias Retraining and Neural Response in Youth

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.

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Key information

Conditions

Alcohol Approach/Avoidance Task Sham Approach/Avoidance Task

Age range

16 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Marijuana Approach Avoidance Training

Behavioral

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.

Primary outcomes

  1. Change in marijuana use from baseline through end of intervention

    Time frame: From 60 days before intervention to end of 3 week 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.

  2. Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task

    Time frame: 3 weeks

    Assessing the change in neural reactivity to marijuana cues before and after the intervention

  3. Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.

    Time frame: 3 weeks

  4. Change in short-term marijuana use from baseline to 1 month post-intervention

    Time frame: From 60 days before intervention 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.

Secondary outcomes

  1. Change in long-term marijuana use from baseline to 1 year post-treatment

    Time frame: From 60 days before intervention to 1 year post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: MJ-AAT

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 30, 2016
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.