Status:
COMPLETED
Use of Donepezil for Treatment of Cocaine Dependence
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Cocaine Abuse and Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00467389
Start Date
February 1 2007
End Date
September 1 2008
Last Update
June 9 2014
Active Locations (1)
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1
VA Medical Center
Kansas City, Missouri, United States, 64128