The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation will assess the effectiveness of topiramate in reducing ethanol
      consumption by alcohol dependent subjects. It also will seek to establish whether topiramate
      can be safely used in this population including whether it might be subject to abuse by
      alcohol dependent individuals.

      A secondary goal of this study is to assess the effects of topiramate on verbal fluency
      during treatment for alcohol dependence.
    

Detailed description: 
      Alcoholism is a disorder that produces extensive morbidity and mortality. Substantial
      progress has been made in the development of medications that can help to promote abstinence
      in alcohol dependent individuals. However, investigations of the most promising drugs,
      particularly naltrexone and acamprosate, suggest that these agents have at best moderate
      efficacy and there is a great need for additional medications for the treatment of
      alcoholism.

      The results of a recent study suggest that the administration of the anticonvulsant agent
      ,topiramate helps alcoholic individuals to maintain abstinence (Johnson et al., 2003). The
      objectives of this study is to determine whether topiramate will reduce the consumption of
      alcohol in subjects dependent on this substance, as has been previously reported.Other study
      objectives are to assess the abuse liability properties of topiramate in alcohol dependent
      subjects and to examine the effects of chronic topiramate administration on cognitive
      functioning.

      This will be a thirteen week long open label clinical trial of the effects of topiramate
      administration on ethanol consumption by alcohol dependent subjects.

      Subjects will be asked to provide informed consent and then will be screened on the same day
      to determine if they meet study eligibility criteria. Subjects will be asked to return to
      provide two urines over the following week.

      Baseline measures of mood, craving, withdrawal, cognitive functioning and physical health
      will be obtained. In the afternoon they will receive their first dose of medication. Their
      responses to this medication challenge will be assessed over a 3-hour period.

      During the drug treatment phase subjects will be asked to come to the clinic weekly for
      assessment and manual guided therapy during weeks 1-4 and biweekly during weeks 6-8. On day
      85 subjects will be seen at the clinic for a termination visit.
    

Intervention name(s): Topiramate (Topamax)
Intervention type(s): Drug
Intervention description(s): Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM & 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM & 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM & 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM
Intervention MeSH terms: Topiramate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcoholism; Heavy Drinking; Alcohol Dependence