Status:
COMPLETED
Clinical Trial of Topiramate for Cocaine Addiction
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment. Th...
Detailed Description
This is an outpatient clinical trial of topiramate treatment for cocaine dependence and reduction of cocaine-associated HIV risk behavior. Topiramate is of high current interest in this regard, having...
Eligibility Criteria
Inclusion
- 18 - 55 years old
- active opioid and cocaine dependence
- seeking treatment for cocaine and opioid dependence
- eligible for methadone maintenance per state and federal regulations
- able and willing to provide a urine sample thrice a week
- willing to answer questionnaires on a weekly basis
- willing to provide breath samples for presence of alcohol thrice weekly
- fluent in the English language
Exclusion
- allergy to sulfonamide drugs
- diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to a risk of acidosis
- history of nephrolithiasis
- HIV positive individuals who meet AIDS criteria by CDC criteria or are taking antiretroviral medications
- serious psychiatric illness (psychosis, dementia)
- glaucoma or family history of glaucoma
- prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine samples on demand
- female participants: being pregnant, lactating, or unwilling to use an effective method of contraception
- use of antiepileptic agents
- benzodiazepine dependence
- latex allergy
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00685178
Start Date
February 1 2007
End Date
September 1 2011
Last Update
July 11 2017
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224