The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Inactive Comparator with Similar Appearance to Active Medication
VA Medical Center
Kansas City, Missouri, United States
Cocaine Safety in Subjects Receiving Donepezil
Patients evaluated for clinical and laboratory adverse events
Time frame: Two weeks
Cocaine Subjective Effects
Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).
Time frame: 3 to 30 minutes
Cocaine Pharmacokinetics
Area-Under-the-Curve for Plasma Concentration
Time frame: 0 to 8 hours
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