Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
Condition: Cannabis Abuse; Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: Topiramate; Placebo
Intervention description: Topiramate (200 mg daily); Placebo (daily)
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 15 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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