Use of Donepezil for Treatment of Cocaine Dependence

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Cholinesterase Inhibitors; Cocaine; Donepezil

Criteria

Inclusion Criteria:

• Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.

Exclusion Criteria:

• Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.

• Has a current psychiatric disorder other than drug abuse or dependence or dementia.

• Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.

• Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.

• Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.

• Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.

• Has had head trauma that resulted in neurological sequelae.

• Has an unstable medical condition, which, in the judgement of investigators, would make participation hazardous.