The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Topiramate (Topamax)
Intervention description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alcoholism; Heavy Drinking; Alcohol Dependence

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. DSM-IV Diagnosis of Alcohol Dependence; Minimal drinking level of 14 drinks per week
             for women and 20 drinks per week for men over a consecutive 30 day period during the
             last 90 days

          2. Intent to stop drinking

          3. Male or female age 18-65

          4. Able to maintain sobriety for 3 consecutive days without the use of detoxification
             medications

          5. Able to provide informed consent and to comprehend study procedures.

          6. If a woman, then is willing to use an effective means of birth control during
             throughout the study period. These include: a. barrier (diaphragm or condom) with
             spermicide b.intrauterine progesterone contraceptive system c. levonorgestrel implant
             d. medroxyprogesterone acetate contraceptive injection e. complete abstinence

        Exclusion Criteria:

          1. Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine,
             or caffeine as assessed by urine toxicology (2 out of 3 Dependent on or extensive
             abuse of drugs or substances other than positive consecutive urines)

          2. DSM IV Axis I diagnoses other than ethanol, caffeine, or nicotine dependence severe
             enough to require treatment with medication or to prevent compliance with the
             protocol.

          3. Currently being treated with disulfiram (Antabuse), naltrexone (ReVia), or acamprosate

          4. Currently being treated with any other psychoactive or other CNS medications or a
             carbonic anhydrase inhibitor (e.g. acetazolamide)

          5. In need of medical detoxification from alcohol.

          6. Prior history of kidney stones.

          7. History of liver disease. ALT or AST 3 times higher than upper range of normal values.

          8. BUN or serum creatinine outside the normal range

          9. Major neurological disorder including seizures

         10. Other major diseases including severe hypertension, renal disease, or cardiac disease.

         11. Prior participation within 60 days in another clinical study.

         12. If female, a positive serum HCG or breast feeding.

         13. If female using oral contraceptives as a means of birth control.

         14. History of allergic sensitivity to topiramate

         15. Pending imprisonment

         16. Cardiac pacemaker or metal surgical implant.

         17. History of angle closure glaucoma.