NCT00467389

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

June 9, 2014

Completed
Last Updated

June 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

April 27, 2007

Results QC Date

December 18, 2013

Last Update Submit

May 21, 2014

Conditions

Cocaine Abuse and Dependence

Keywords

AcetylcholineAcetylcholinesteraseButyrylcholinesteraseCholinesterase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Cocaine Safety in Subjects Receiving Donepezil

    Patients evaluated for clinical and laboratory adverse events

    Two weeks

Secondary Outcomes (2)

  • Cocaine Subjective Effects

    3 to 30 minutes

  • Cocaine Pharmacokinetics

    0 to 8 hours

Study Arms (2)

Oral Placebo First

EXPERIMENTAL

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

Drug: Donepezil, 5 mg dailyOther: Oral Placebo

Donepezil First

EXPERIMENTAL

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

Drug: Donepezil, 5 mg dailyOther: Oral Placebo

Interventions

Donepezil, 5 mg dailyDRUG

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

Also known as: Aricept
Donepezil FirstOral Placebo First
Oral PlaceboOTHER

Inactive Comparator with Similar Appearance to Active Medication

Also known as: Inactive Comparator
Donepezil FirstOral Placebo First

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (1)

  • 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.

    PMID: 19836169RESULT

MeSH Terms

Conditions

Cocaine-Related DisordersPainButyrylcholinesterase deficiency

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Kenneth Grasing
Organization
Substance Abuse Research Laboratory, Kansas City VA Medical Center
kenneth.grasing@va.gov
(816) 922-2756

Study Officials

  • Kenneth Grasing, MD

    VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 9, 2014

Results First Posted

June 9, 2014

Record last verified: 2014-05

Locations

US(1)