Back to resultsMarijuana Approach Bias Retraining and Neural Response in Youth (MJ-AAT)
Primary Purpose
Alcohol Approach/Avoidance Task, Sham Approach/Avoidance Task
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marijuana Approach Avoidance Training
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol Approach/Avoidance Task
Eligibility 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Approach Avoidance Training Condition
Sham Condition
Arm Description
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.
The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull.
Outcomes
Primary Outcome Measures
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.
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
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02723149
First Posted
March 14, 2016
Last Updated
September 26, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02723149
Brief Title
Marijuana Approach Bias Retraining and Neural Response in Youth
Acronym
MJ-AAT
Official Title
Marijuana Approach Bias Retraining and Neural Response in Youth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Approach/Avoidance Task, Sham Approach/Avoidance Task
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Approach Avoidance Training Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Condition
Arm Type
Sham Comparator
Arm Description
The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull.
Intervention Type
Behavioral
Intervention Name(s)
Marijuana Approach Avoidance Training
Intervention Description
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 Outcome Measure Information:
Title
Change in marijuana use from baseline through end of intervention
Description
Assessing the change in marijuana use (as measured by number of days used marijuana X hits per day) from baseline to end of intervention.
Time Frame
From 60 days before intervention to end of 3 week intervention
Title
Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task
Description
Assessing the change in neural reactivity to marijuana cues before and after the intervention
Time Frame
3 weeks
Title
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.
Time Frame
3 weeks
Title
Change in short-term marijuana use from baseline to 1 month post-intervention
Description
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.
Time Frame
From 60 days before intervention to 1 month post-intervention
Secondary Outcome Measure Information:
Title
Change in long-term marijuana use from baseline to 1 year post-treatment
Description
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.
Time Frame
From 60 days before intervention to 1 year post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay M Squeglia, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Marijuana Approach Bias Retraining and Neural Response in Youth
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