Conditions: Cocaine Abuse and Dependence
Keywords: Acetylcholine Acetylcholinesterase Butyrylcholinesterase Cholinesterase Inhibitor
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

Detailed description:
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.

Arms:
arm 1: Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil arm 2: Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.

Interventions: intervention 1: Donepezil, 5 mg daily intervention 2: Oral Placebo
Intervention descriptions: intervention 1: This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease. intervention 2: Inactive Comparator with Similar Appearance to Active Medication

Protocol document: