Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cocaine Dependence
In brief
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.
Key facts
- Study ID
- NCT01137890
- Run by
- Johns Hopkins University
- People needed
- 19
- Starts
- 2010-06-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2017-09-05
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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