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Use of Donepezil for Treatment of Cocaine Dependence

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ClinicalTrials.gov Identifier: NCT00467389
Recruitment Status : Completed
First Posted : April 30, 2007
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

Condition or disease Intervention/treatment Phase
Cocaine Abuse and Dependence Drug: Donepezil, 5 mg daily Other: Oral Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Donepezil Effects on Cocaine Craving and Pharmacokinetics
Study Start Date : February 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Oral Placebo First
Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil
Drug: Donepezil, 5 mg daily
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Other Name: Aricept
Other: Oral Placebo
Inactive Comparator with Similar Appearance to Active Medication
Other Name: Inactive Comparator
Experimental: Donepezil First
Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.
Drug: Donepezil, 5 mg daily
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Other Name: Aricept
Other: Oral Placebo
Inactive Comparator with Similar Appearance to Active Medication
Other Name: Inactive Comparator


Outcome Measures

Primary Outcome Measures :
  1. Cocaine Safety in Subjects Receiving Donepezil [ Time Frame: Two weeks ]
    Patients evaluated for clinical and laboratory adverse events


Secondary Outcome Measures :
  1. Cocaine Subjective Effects [ Time Frame: 3 to 30 minutes ]
    Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).

  2. Cocaine Pharmacokinetics [ Time Frame: 0 to 8 hours ]
    Area-Under-the-Curve for Plasma Concentration


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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 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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467389


Locations
United States, Missouri
VA Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kenneth Grasing, MD VA Office of Research and Development
More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00467389     History of Changes
Other Study ID Numbers: NEUA-014-05S
First Posted: April 30, 2007    Key Record Dates
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014
Last Verified: May 2014

Keywords provided by VA Office of Research and Development:
Acetylcholine
Acetylcholinesterase
Butyrylcholinesterase
Cholinesterase Inhibitor

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Cocaine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents