Use of Donepezil for Treatment of Cocaine Dependence
This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00467389
First received: April 27, 2007
Last updated: March 17, 2011
Last verified: March 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Abuse and Dependence |
Drug: Donepezil, 5 mg daily |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Donepezil Effects on Cocaine Craving and Pharmacokinetics |
Resource links provided by NLM:
Further study details as provided by Department of Veterans Affairs:
Primary Outcome Measures:
- The safety of cocaine administration in subjects receiving donepezil will be evaluated by electrocardiogram monitoring, self-reported adverse events, blood pressure, heart rate, 12-lead electrocardiograms, and safety laboratories. [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Plasma levels of cocaine and metabolites will be determined by liquid chromatography-tandem mass spectrometry after intravenous cocaine administration in placebo- and donepezil- treated subjects. Baseline and cocaine-induced increases in plasma HVA will [ Time Frame: Subjective effects of cocaine will be measured by VAS, BSCS, and the Multiple Choice Questionnaire. Additional psychometric measures will include the BSI, Beck Depression Inventory, POMS, and the Addiction Research Center Inventory. ]
| Estimated Enrollment: | 42 |
| Study Start Date: | February 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Donepezil, 5 mg daily
|
Drug: Donepezil, 5 mg daily
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Other Name: Aricept
|
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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 DSM-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
- Has received opiate-substitution therapy (methadone, LAAM, 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.
Contacts and Locations More Information
Publications:
| Responsible Party: | Grasing, Kenneth - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00467389 History of Changes |
| Other Study ID Numbers: | NEUA-014-05S |
| Study First Received: | April 27, 2007 |
| Last Updated: | March 17, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
Acetylcholine Acetylcholinesterase Butyrylcholinesterase Cholinesterase Inhibitor |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cholinesterase Inhibitors Donepezil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013