drugset / Trial / NCT00577005

Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients

NCT00577005

RandomizedParallel-groupTriple-blindTreatment

Summary

Concurrent dependence on cocaine occurs in up to 50% of the over one million opiate dependent patients in spite of methadone maintenance treatment being highly effective for opiate dependence and having excellent treatment retention. Cocaine dependence has remained largely unresponsive to medications both in and outside of these methadone programs. We have initial data from our open-label study with levetiracetam showing that this medication is well tolerated and may reduce cocaine use in this cocaine-abusing methadone treated population. The specific aim of this study is to evaluate the efficacy of levetiracetam 3 grams/day in modifying cocaine-using behavior, reducing cocaine craving and attenuating cocaine's reinforcing effect among methadone-maintained patients. The primary outcomes will be reduction in cocaine use as assessed by self-report and thrice-weekly urinalyses. Secondary outcomes will include weeks in treatment (retention) and change in measures of cocaine craving, anxiety symptoms and opiate withdrawal symptoms.

Timeline

Start
2007-07
Primary completion
2008-06
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 3000 mg