Use of Donepezil for Treatment of Cocaine Dependence

May 21, 2014 updated by: US Department of Veterans Affairs

Donepezil Effects on Cocaine Craving and Pharmacokinetics

The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Va Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Aricept
Other: Oral Placebo
Inactive Comparator with Similar Appearance to Active Medication
Other Names:
  • 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 Names:
  • Aricept
Other: Oral Placebo
Inactive Comparator with Similar Appearance to Active Medication
Other Names:
  • Inactive Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cocaine Safety in Subjects Receiving Donepezil
Time Frame: Two weeks
Patients evaluated for clinical and laboratory adverse events
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 to 30 minutes
Cocaine Pharmacokinetics
Time Frame: 0 to 8 hours
Area-Under-the-Curve for Plasma Concentration
0 to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Kenneth Grasing, MD, Va Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

April 27, 2007

First Submitted That Met QC Criteria

April 27, 2007

First Posted (ESTIMATE)

April 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUA-014-05S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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