Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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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 significant burden on our society, as more than a half million cocaine dependent individuals are seeking treatment every year. Medications that act to antagonize the glutamate system and/or increase the GABA-system are new targets in the search towards effective cocaine treatment. ZNS is part of a new line of antiepileptic agents that act both as glutamate antagonists and to enhance the Gamma-AminoButyric acid (GABA) system. Topiramate, a similar agent, showed a positive signal in a pilot trial for cocaine dependence. ZNS has the advantages of a longer half-life requiring only once a day dosing and, being better tolerated, it requires a shorter induction phase and can be administered at higher doses. We hypothesize that ZNS in moderate to high doses will attenuate the central effect of cocaine and improve the neural perturbations resulting from cocaine use, thus decreasing cocaine craving. Healthy, adult cocaine dependent volunteers will be enrolled on our residential unit for 44 days for this double-blind within subject study. The pharmacodynamic interactions between ZNS and cocaine will be measured in cocaine self-administration procedure offering alternative reinforcers with monetary values. Cocaine reinforcing effect will be evaluated over a range of doses, and subjective and objective outcomes on mood and behavior will be collected. In addition, the effect of ZNS on ad-lib smoking will be studied on the days when no other procedure interferes with smoking behaviors. Neurocognitive and psychomotor effects of ZNS treatment will also be studied with an extensive test battery on the day of the week when no cocaine is administered. This study will explore the potential therapeutic effect of ZNS for the treatment of cocaine dependence while providing necessary safety assessments required for possible future outpatient clinical trials.

Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zonisamide

Participants administered blind capsules containing either placebo or zonisamide.

Group Type EXPERIMENTAL

Zonisamide

Intervention Type DRUG

Eight capsules administered daily in split doses at 22:00 and 09:00.

Cocaine Hydrochloride

Intervention Type DRUG

Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.

Neurocognitive and Performance Battery

Intervention Type BEHAVIORAL

Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.

Smoking Assessments

Intervention Type BEHAVIORAL

Participants answer questions about smoking and smoking behaviors are monitored.

Placebo

Participants administered only placebo capsules containing lactose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules administered in split doses at 22:00 and 09:00.

Cocaine Hydrochloride

Intervention Type DRUG

Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.

Neurocognitive and Performance Battery

Intervention Type BEHAVIORAL

Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.

Smoking Assessments

Intervention Type BEHAVIORAL

Participants answer questions about smoking and smoking behaviors are monitored.

Interventions

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Zonisamide

Eight capsules administered daily in split doses at 22:00 and 09:00.

Intervention Type DRUG

Placebo

capsules administered in split doses at 22:00 and 09:00.

Intervention Type DRUG

Cocaine Hydrochloride

Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.

Intervention Type DRUG

Neurocognitive and Performance Battery

Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.

Intervention Type BEHAVIORAL

Smoking Assessments

Participants answer questions about smoking and smoking behaviors are monitored.

Intervention Type BEHAVIORAL

Other Intervention Names

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Zonegran, CAS 68291-97-4, CAS 50-36-2 methylbenzoylecgonine benzoylmethylecgonine C17H21NO4

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No