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)
Primary Purpose: Treatment
|Official Title:||Donepezil Effects on Cocaine Craving and Pharmacokinetics|
- Cocaine safety in subjects receiving donepezil [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]Patients will be evaluated for clinical and laboratory adverse events
- Cocaine pharmacokinetics and subjective effects [ Time Frame: 8 Hours ] [ Designated as safety issue: No ]Plasma cocaine determined by mass spectrophotometry and subjective effects by VAS (visual analogue scale).
|Study Start Date:||February 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
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|