Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Study Overview
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Brief Summary
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Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.

Official Title
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Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Conditions
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Cannabis Abuse, Cannabis Dependence

Intervention / Treatment
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* Drug: Topiramate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 15 to 20 years old (inclusive) Non-treatment seeking for cannabis abuse or dependence Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study If younger than 18 years old, informed consent from a parent or legal guardian is required Used cannabis at least 2 days per week during the past 30 days Exclusion Criteria: Treatment seeking or a recent history of treatment for cannabis abuse or dependence Endorses a current commitment to stop using cannabis Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis History of renal impairment, renal stones, seizures, or unstable hypertension Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female Took a psychotropic medication in the past 30 days Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor Suicidal A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders Significant alcohol withdrawal symptoms Known sensitivity to topiramate

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topiramate<br>Topiramate (200 mg daily) | Drug: Topiramate<br>* Topiramate (200 mg daily)<br>* Other names: Topamax;|
| Placebo Comparator: Sugar pill<br> | Drug: Placebo<br>* Placebo (daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannabis Use | Frequency of Cannabis Use (Percent Use Days Per Week) | Weeks 1-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of Cannabis Use | Total Grams of Cannabis Use Per week | Weeks 1-6 | 
| Amount of Cannabis Use Per Use Day | Average Grams of Cannabis Used Per Use Day | Weeks 1-6 |