Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA) Yale University