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

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ClinicalTrials.gov Identifier: NCT02723149
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE November 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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.
  • 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
  • Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times. [ Time Frame: 3 weeks ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02723149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Marijuana Approach Bias Retraining and Neural Response in Youth
Official Title  ICMJE Marijuana Approach Bias Retraining and Neural Response in Youth
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Alcohol Approach/Avoidance Task
  • Sham Approach/Avoidance Task
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Marijuana Approach Avoidance Training
  • 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.
    Intervention: Behavioral: Marijuana Approach Avoidance Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
40
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723149
Other Study ID Numbers  ICMJE 44583
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lindsay M Squeglia, PhD Assistant Professor
PRS Account Medical University of South Carolina
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP