This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. There are no medications yet proven uniquely effective for treatment of cocaine dependence although significant data using agonists are emerging. NIH/National Institute on Drug Abuse (NIDA) has an active Medication Development Program examining pharmacotherapy for cocaine dependence/abuse. Safety data for GBR 12909 have been collected and are accumulating. This is a human laboratory clinical pharmacology study that will further evaluate GBR and potential interactions between intravenous Cocaine HCL administered i.v. (pbo, 20 mg, 40 mg) and treatment with GBR 12909 (50, 75, and 100 mg) administered orally to cocaine experienced, non treatment seeking volunteers. The protocol was developed in consultation between external scientists and NIDA Scientists and uses the standard NIH/NIDA 'interaction template'. It was reviewed and revised in consultation with US Food and Drug Administration scientists. The three doses (50, 75, or 100 mg) will be administered in increasing order with each dose evaluated in all subjects before beginning the next cohort at the next higher dose. There will be three cohorts of 8 subjects (24 total). In each cohort, 6 will receive GBR and 2 will receive placebo. All will undergo the PBO/Cocaine HCL infusion protocol. If successful, this study will lead to outpatient clinical trials with GBR 12909 and the possibility of the first approved, uniquely effective pharmacotherapy for cocaine dependence.
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