Verified February 2016 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT02723149
First received: March 14, 2016
Last updated: March 23, 2016
Last verified: February 2016
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.
| Alcohol Approach/Avoidance Task Sham Approach/Avoidance Task |
Behavioral: Marijuana Approach Avoidance Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
| Official Title: | Marijuana Approach Bias Retraining and Neural Response in Youth |
- Change in marijuana use from baseline through end of intervention [ Time Frame: From 60 days before intervention to end of 3 week intervention ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2015 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| 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. |
| Ages Eligible for Study: | 16 Years to 21 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02723149
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Lindsay M Squeglia, PhD 842-792-5451 squegli@nullmusc.edu | |
| Principal Investigator: Lindsay M Squeglia, PhD | |
Medical University of South Carolina
| Principal Investigator: | Lindsay M Squeglia, PhD | Assistant Professor |
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT02723149 History of Changes |
| Other Study ID Numbers: | 44583 |
| Study First Received: | March 14, 2016 |
| Last Updated: | March 23, 2016 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on September 13, 2016