Use of Donepezil for Treatment of Cocaine Dependence
Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Abuse and Dependence
Intervention: Donepezil, 5 mg daily (Drug); Oral Placebo (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Kenneth Grasing, MD, Principal Investigator, Affiliation: Department of Veterans Affairs
Summary
The purpose of this study is to determine the safety of intravenous cocaine in subjects
receiving oral donepezil.
Clinical Details
Official title: Donepezil Effects on Cocaine Craving and Pharmacokinetics
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Cocaine Safety in Subjects Receiving Donepezil
Secondary outcome: Cocaine Subjective EffectsCocaine Pharmacokinetics
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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.
Locations and Contacts
VA Medical Center, Kansas City, Missouri 64128, United States
Additional Information
Starting date: February 2007
Last updated: May 21, 2014
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