Topiramate Treatment of Problem Drinkers
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: topiramate; placebo
Intervention description: up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper); placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
Intervention MeSH terms: Topiramate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Randomized Trial; Medication for Heavy Drinking; Topiramate Treatment

Summary:

      The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing
      drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of
      up to 200mg/day, topiramate will be well tolerated in this patient population and that,
      compared to placebo treatment, topiramate will result in a greater reduction in the frequency
      of both drinking days and heavy drinking days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 to 65 years, inclusive;

          -  have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18
             standard drinks for women;

          -  be able to read English at the 8th grade or higher level and show no evidence of
             significant cognitive impairment;

          -  be willing to nominate an individual who will know the patient's whereabouts in order
             to facilitate follow up during the study;

          -  if a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral
             oophorectomy, tubal ligation or who are less than two years postmenopausal), must be
             non-lactating, practicing a reliable method of birth control, and have a negative
             serum pregnancy test prior to initiation of treatment;

          -  if applicable, individuals being treated with a single antidepressant that has been
             stable in dosage for a minimum of four weeks; and

          -  be willing to provide signed, informed consent to participate in the study (including
             a willingness to reduce drinking to non-hazardous levels).

        Exclusion Criteria:

          -  a current, clinically significant physical disease or abnormality on the basis of
             medical history, physical examination, or routine laboratory evaluation, including
             direct bilirubin elevations of >110% or transaminase elevations >300% normal (We will
             not exclude patients with hypertension, diabetes mellitus, asthma or other common
             medical conditions, as long as these are adequately controlled and the patient has an
             ongoing relationship with a primary-care practitioner);

          -  a history of nephrolithiasis;

          -  a history of glaucoma;

          -  a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or
             psychotic major depression, panic disorder, borderline or antisocial personality
             disorder, organic mood or mental disorders, eating disorder, or substantial suicide or
             violence risk) on the basis of history or psychiatric examination;

          -  a current Diagnostic & Statistical Manual of Mental Disorders 4th ed (DSM-IV)
             diagnosis of drug dependence (other than nicotine dependence);

          -  a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV)
             diagnosis of alcohol dependence that is clinically moderate or severe;

          -  a history of hypersensitivity to topiramate;

          -  currently taking any tricyclic antidepressant (e.g., Adapin (doxepin), Anafranil
             (clomipramine), Elavil (amitryptyline), Pamelor (nortryptyline), Tofranil
             (imipramine), Sinequan (doxepin); or

          -  are considered by the investigators to be an unsuitable candidate for receipt of an
             investigational drug.