This contract will provide a network of three clinical trial sites that will provide clinical trials services for the conduct of Phase I and II clinical trials and clinical pharmacology studies. University of Cincinnati is one of three sites in this network. The clinical sites will evaluate systematically the clinical utility of potential pharmacotherapeutic compounds in order to develop effective medications for the treatment of drug abuse and addiction. Specifically. Pharmacotherapeutic compounds to reduce the use of cocaine and other stimulants will be investigated. The results of these clinical trials will be the basis to advance the candidate compounds for further medication development (i.e., Phase III clinical trial) and ultimately submitted to the FDA in support of a New Drug Application (NDA) submission. The major emphasis of this contract shall be on clinical trials to evaluate the clinical pharmacology and efficacy and safety profiles of the candidate compounds.
| Malcolm, Robert; Swayngim, Karla; Donovan, Jennifer L et al. (2006) Modafinil and cocaine interactions. Am J Drug Alcohol Abuse 32:577-87 |
| Donovan, Jennifer L; DeVane, C Lindsay; Malcolm, Robert J et al. (2005) Modafinil influences the pharmacokinetics of intravenous cocaine in healthy cocaine-dependent volunteers. Clin Pharmacokinet 44:753-65 |
| Myrick, Hugh; Malcolm, Robert; Taylor, Brent et al. (2004) Modafinil: preclinical, clinical, and post-marketing surveillance--a review of abuse liability issues. Ann Clin Psychiatry 16:101-9 |
| Donovan, Jennifer L; Malcolm, Robert J; Markowitz, John S et al. (2003) Chiral analysis of d- and l-modafinil in human serum: application to human pharmacokinetic studies. Ther Drug Monit 25:197-202 |
