Clinical trial NCT02723149: Marijuana Approach Bias Retraining and Neural Response in Youth
Official title: Marijuana Approach Bias Retraining and Neural Response in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Approach/Avoidance Task
Sham Approach/Avoidance Task
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 41
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Change in marijuana use from baseline through end of intervention
timeFrame: From 60 days before intervention to end of 3 week intervention
measure: Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task
timeFrame: 3 weeks
measure: Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.
timeFrame: 3 weeks
measure: Change in short-term marijuana use from baseline to 1 month post-intervention
timeFrame: From 60 days before intervention to 1 month post-intervention
Secondary outcomes:
measure: Change in long-term marijuana use from baseline to 1 year post-treatment
timeFrame: From 60 days before intervention to 1 year post-intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Assistant Professor
name: Lindsay M Squeglia, PhD
role: PRINCIPAL_INVESTIGATOR
References: