Status:
COMPLETED
The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 th...
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 ...
Eligibility Criteria
Inclusion
- 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
- Intent to stop drinking
- Male or female age 18-65
- Able to maintain sobriety for 3 consecutive days without the use of detoxification medications
- Able to provide informed consent and to comprehend study procedures.
- 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
- 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)
- 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.
- Currently being treated with disulfiram (Antabuse), naltrexone (ReVia), or acamprosate
- Currently being treated with any other psychoactive or other CNS medications or a carbonic anhydrase inhibitor (e.g. acetazolamide)
- In need of medical detoxification from alcohol.
- Prior history of kidney stones.
- History of liver disease. ALT or AST 3 times higher than upper range of normal values.
- BUN or serum creatinine outside the normal range
- Major neurological disorder including seizures
- Other major diseases including severe hypertension, renal disease, or cardiac disease.
- Prior participation within 60 days in another clinical study.
- If female, a positive serum HCG or breast feeding.
- If female using oral contraceptives as a means of birth control.
- History of allergic sensitivity to topiramate
- Pending imprisonment
- Cardiac pacemaker or metal surgical implant.
- History of angle closure glaucoma.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00329407
Start Date
September 1 2003
End Date
June 1 2008
Last Update
September 8 2010
Active Locations (1)
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1
Boston University Dept of Psychiatry Clinical Studies Unit
Boston, Massachusetts, United States, 02118