Effect of Zonisamide on Cocaine Reinforcement, Craving, & Relapse

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01137890
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 2010
Completion date	August 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04994821` - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study	Phase 2
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Completed	`NCT01402492` - Cocaine Use Reduction With Buprenorphine	Phase 2/Phase 3
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT00880997` - The Efficacy of Doxazosin for Cocaine Users	Phase 1
Completed	`NCT00566969` - Cocaine Withdrawal and Pharmacotherapy Response	N/A
Completed	`NCT00585520` - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues	Phase 1
Completed	`NCT00368290` - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior	Phase 2
Completed	`NCT00385801` - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence	Phase 2
Completed	`NCT00322309` - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects	Phase 2
Completed	`NCT00167245` - Topiramate for Alcohol and Cocaine Dependence	Phase 2
Completed	`NCT00842517` - Long Term Maintenance of Drug Abstinence	Phase 1
Not yet recruiting	`NCT05974202` - rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder	Phase 2
Completed	`NCT04411914` - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid	Phase 1
Active, not recruiting	`NCT03266939` - Rebalancing the Serotonergic System in Cocaine Dependence	Phase 1
Completed	`NCT02563769` - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study	Phase 1
Recruiting	`NCT06159387` - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts	Phase 4
Terminated	`NCT02935101` - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants	Phase 2
Completed	`NCT02018263` - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans	Phase 1
Withdrawn	`NCT01406522` - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms