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Trial record 16 of 706 for:    marijuana

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

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ClinicalTrials.gov Identifier: NCT02723149
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : December 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Alcohol Approach/Avoidance Task Sham Approach/Avoidance Task Behavioral: Marijuana Approach Avoidance Training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Marijuana Approach Bias Retraining and Neural Response in Youth
Study Start Date : November 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723149


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Lindsay M Squeglia, PhD Assistant Professor
More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02723149     History of Changes
Other Study ID Numbers: 44583
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016