Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking; Underage Drinking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will help to determine whether the medication, topiramate, reduces alcohol use
      among adolescents with alcohol dependence. It will also help answer the question, "How does
      topiramate reduce drinking in teenagers?" Understanding how topiramate may reduce drinking in
      adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and
      help to identify additional medications that may hold promise for improving treatment
      outcomes for youth.
    

Detailed description: 
      Adolescent alcohol use is associated with myriad adverse legal, health, and educational
      consequences and contributes to the leading causes of mortality among youth. Yet despite the
      magnitude of this public health problem, treatment initiatives for youth remain inadequate.
      Given these data, the National Institute on Alcohol Abuse and Alcoholism identified the
      critical need for medications development research for youth with the goal of identifying
      promising agents for which large-scale clinical trials are justified. The long-term goal of
      this research program is to improve pharmacotherapy for alcoholism. The major objective of
      this project is to address the urgent need for empirical data on medications that may benefit
      youth. For the past 10 years our research program has successfully paired human laboratory
      paradigms with ecological momentary assessment (EMA), whereby research participants use
      handheld electronic diaries to monitor their drinking, craving, and sensitivity to alcohol in
      real time in their natural environment. Using this approach, we identified mechanisms by
      which medications act and patient characteristics that moderate these effects. The proposed
      study will test if and how topiramate (TPM), an anticonvulsant shown to be efficacious for
      treating adults, reduces drinking in youth. To this end, we will randomize adolescent problem
      drinkers to TPM or placebo for 8 weeks, in combination with biweekly motivational enhancement
      therapy sessions, using a two-group, double-blind design. While at the target dose (200
      mg/day) youth will complete EMA in their natural environment. In addition, youth will
      complete alcohol cue reactivity assessments in the laboratory to test the effects of TPM on
      cue-elicited craving and physiological reactivity in a controlled environment. Youth will
      complete 6- and 12-month follow-up assessments to determine whether any benefits are
      sustained. This study will provide much needed data on the tolerability and efficacy of TPM
      with adolescents, while adding important new information about the biobehavioral mechanisms
      of TPM action in youth.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topiramate (200 mg daily); Matching placebo capusules ("sugar pills"
Other intervention name(s): Topamax; "Sugar Pill"
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment