Efficacy of Varenicline in Methadone-Stabilized Cocaine Users
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Cocaine addiction continues to be an important public health problem in the US with a
significant cost to the individual and society. Among substance abusers, cocaine use has been
recognized as a significant problem especially in methadone-maintenance patients. In several
studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those
in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer
1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor
clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective
pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is
of great importance. Unfortunately, such effective pharmacotherapies do not exist.
1. To determine the safety and tolerability of varenicline in cocaine-using
methadone-stabilized subjects.
2. To determine if varenicline is efficacious in reducing cocaine-use in
methadone-stabilized subjects.
Phase:
N/A
Details
Lead Sponsor:
Yale University
Collaborators:
National Institute on Drug Abuse (NIDA) US Department of Veterans Affairs VA Office of Research and Development