Use of Donepezil for Treatment of Cocaine Dependence
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Donepezil Effects on Cocaine Craving and Pharmacokinetics|
- The safety of cocaine administration in subjects receiving donepezil will be evaluated by electrocardiogram monitoring, self-reported adverse events, blood pressure, heart rate, 12-lead electrocardiograms, and safety laboratories. [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
- Plasma levels of cocaine and metabolites will be determined by liquid chromatography-tandem mass spectrometry after intravenous cocaine administration in placebo- and donepezil- treated subjects. Baseline and cocaine-induced increases in plasma HVA will [ Time Frame: Subjective effects of cocaine will be measured by VAS, BSCS, and the Multiple Choice Questionnaire. Additional psychometric measures will include the BSI, Beck Depression Inventory, POMS, and the Addiction Research Center Inventory. ]
|Study Start Date:||February 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Donepezil, 5 mg daily
Drug: Donepezil, 5 mg daily
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Other Name: Aricept
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.
|United States, Missouri|
|VA Medical Center|
|Kansas City, Missouri, United States, 64128|
|Principal Investigator:||Kenneth Grasing, MD||Department of Veterans Affairs|