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Use of Donepezil for Treatment of Cocaine Dependence

Primary Purpose

Cocaine Abuse and Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Donepezil, 5 mg daily

Oral Placebo

About this trial

This is an interventional treatment trial for Cocaine Abuse and Dependence focused on measuring Acetylcholine, Acetylcholinesterase, Butyrylcholinesterase, Cholinesterase Inhibitor

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Oral Placebo First

Donepezil First

Arm Description

Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil

Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.

Outcomes

Primary Outcome Measures

Cocaine Safety in Subjects Receiving Donepezil

Patients evaluated for clinical and laboratory adverse events

Secondary Outcome Measures

Cocaine Subjective Effects

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).

Cocaine Pharmacokinetics

Area-Under-the-Curve for Plasma Concentration

Full Information

NCT ID

NCT00467389

First Posted

April 27, 2007

Last Updated

May 21, 2014

Sponsor

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT00467389

Brief Title

Use of Donepezil for Treatment of Cocaine Dependence

Official Title

Donepezil Effects on Cocaine Craving and Pharmacokinetics

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Abuse and Dependence

Keywords

Acetylcholine, Acetylcholinesterase, Butyrylcholinesterase, Cholinesterase Inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Placebo First

Arm Type

Experimental

Arm Description

Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil

Arm Title

Donepezil First

Arm Type

Experimental

Arm Description

Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.

Intervention Type

Drug

Intervention Name(s)

Donepezil, 5 mg daily

Other Intervention Name(s)

Aricept

Intervention Description

This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.

Intervention Type

Other

Intervention Name(s)

Oral Placebo

Other Intervention Name(s)

Inactive Comparator

Intervention Description

Inactive Comparator with Similar Appearance to Active Medication

Primary Outcome Measure Information:

Title

Cocaine Safety in Subjects Receiving Donepezil

Description

Patients evaluated for clinical and laboratory adverse events

Time Frame

Two weeks

Secondary Outcome Measure Information:

Title

Cocaine Subjective Effects

Description

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).

Time Frame

3 to 30 minutes

Title

Cocaine Pharmacokinetics

Description

Area-Under-the-Curve for Plasma Concentration

Time Frame

0 to 8 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Grasing, MD

Organizational Affiliation

VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19836169

Citation

Grasing K, Mathur D, Newton TF, DeSouza C. Donepezil treatment and the subjective effects of intravenous cocaine in dependent individuals. Drug Alcohol Depend. 2010 Feb 1;107(1):69-75. doi: 10.1016/j.drugalcdep.2009.09.010.

Results Reference

result

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Use of Donepezil for Treatment of Cocaine Dependence

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