Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine; Zonisamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.