Use of Donepezil for Treatment of Cocaine Dependence

NCT ID: NCT00467389

Last Updated: 2014-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-09-30

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.

Conditions

Cocaine Abuse and Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral Placebo First

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

Group Type: EXPERIMENTAL

Donepezil, 5 mg daily

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: OTHER

Inactive Comparator with Similar Appearance to Active Medication

Donepezil First

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

Group Type: EXPERIMENTAL

Donepezil, 5 mg daily

Intervention Type: DRUG

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

Oral Placebo

Intervention Type: OTHER

Inactive Comparator with Similar Appearance to Active Medication

Interventions

Donepezil, 5 mg daily

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

Intervention Type: DRUG

Oral Placebo

Inactive Comparator with Similar Appearance to Active Medication

Intervention Type: OTHER

Other Intervention Names

Aricept; Inactive Comparator

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Grasing, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center

Locations

VA Medical Center

Kansas City, Missouri, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19836169 (View on PubMed)

Other Identifiers

NEUA-014-05S

Identifier Type: -

Identifier Source: org_study_id