The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Topiramate

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.