Status:
COMPLETED
Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
21-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a residential pilot trial to evaluate the pharmacodynamic interaction between zonisamide and cocaine, with the goal of evaluating zonisamide's potential for the treatment of cocaine dependence...
Detailed Description
This is a residential pilot trial to evaluate the effect of zonisamide (ZNS) on cocaine reinforcement, craving and relapse. Cocaine addiction remains a major social and medical problem that imposes a ...
Eligibility Criteria
Inclusion
- Age at least 21 years old, not older than 45 years.
- Evidence of cocaine dependence.
- Not seeking treatment for cocaine abuse.
- Able and willing to be restricted to our unit for 6-7 weeks.
- Able to answer frequent questionnaires reliably and consistently.
- Smoker.
Exclusion
- Allergy to Sulfonamide drugs (e.g. topiramate, zonisamide, sulfamethoxazole/trimethoprim).
- Diabetes, respiratory insufficiency, renal tubular acidosis or renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to acidosis.
- Renal insufficiency defined as serum creatine \> 1.30 mg/DL for males or \> 1.03 mg/DL for females.
- History of nephrolithiasis, unexplained hematuria on screening urinalysis.
- History of head injury (with loss of consciousness longer than a few minutes).
- History of seizure, or use of antiepileptic medications.
- HIV positive individuals who meet AIDS by Centers for Disease Control (CDC) criteria or are on antiretroviral medications.
- BMI \< 19 or BMI \> 34.
- Total cholesterol \> 240mg%.
- Serous psychiatric illness with psychosis, dementia.
- Glaucoma, family history of glaucoma, one-sided blindness.
- For female participants: being pregnant, lactating or not using an effective method of contraception.
- Physical dependence on any drug other than cocaine, nicotine, or caffeine.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01137890
Start Date
June 1 2010
End Date
August 1 2013
Last Update
September 5 2017
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224