Use of Donepezil for Treatment of Cocaine Dependence - Full Text View

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00467389

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 II

Drug Information available for: Acetylcholine Acetylcholine chloride 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Donepezil Effects on Cocaine Craving and Pharmacokinetics

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
1: Experimental	Drug: Donepezil, 5 mg daily

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467389

Locations

United States, Missouri
VA Medical Center
Kansas City, Missouri, United States, 64128

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Kenneth Grasing, MD

Department of Veterans Affairs

More Information

Responsible Party:	Department of Veterans Affairs ( Grasing, Kenneth - Principal Investigator )
Study ID Numbers:	NEUA-014-05S
Study First Received:	April 27, 2007
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00467389
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

Acetylcholine
Acetylcholinesterase
Butyrylcholinesterase
Cholinesterase Inhibitor

Study placed in the following topic categories:

Cocaine-Related Disorders
Mental Disorders
Donepezil
Substance-Related Disorders

Disorders of Environmental Origin
Acetylcholine
Cocaine

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009