NCT01495195

Brief Summary

No medications are currently available for treatment of psychostimulant addiction, a compulsive preoccupation with use of cocaine and related compounds. Donepezil is a medication that is currently prescribed for Alzheimer's disease, and selegiline is a medication used for treatment of Parkinson's Disease. Both of these medications can decrease the amount of cocaine injections that laboratory animals choose to inject by vein. This project will determine if combined treatment with donepezil and selegiline can also decrease cocaine-motivated behavior for human subjects in a laboratory setting.

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 2012

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

December 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

1.2 years

First QC Date

December 15, 2011

Last Update Submit

December 17, 2013

Conditions

Cocaine Use Disorders

Keywords

AcetylcholineCholinesterasesCocaineSelf-Administration

Outcome Measures

Primary Outcomes (1)

  • Changes in cocaine-reinforced behavior

    Participants will make a series of choices between vouchers with an ascending monetary value and intravenous injections of cocaine

    days 2 and 24 of dosing

Secondary Outcomes (1)

  • How well the study medications are tolerated

    33 days of dosing

Study Arms (4)

Donepezil, high-dose

EXPERIMENTAL

Titration of donepezil to 22.5 mg daily

Drug: High-dose donepezil

Selegiline & low-dose donepezil

EXPERIMENTAL

Low-Dose Donepezil \[titrated to 10 mg daily\] and transdermal selegiline \[6 mg daily\]

Drug: Low-dose donepezilDrug: Selegiline

Selegiline & high-dose donepezil

EXPERIMENTAL

High-Dose Donepezil \[titrated to 22.5 mg daily\] and transdermal selegiline \[6 mg daily\]

Drug: High-dose donepezilDrug: Selegiline

Sugar pill

PLACEBO COMPARATOR

Inert pill for comparison

Drug: Placebo

Interventions

High-dose donepezilDRUG

Donepezil titrated to 22.5 mg daily

Also known as: Aricept
Donepezil, high-doseSelegiline & high-dose donepezil
Low-dose donepezilDRUG

Donepezil titrated to 10 mg daily

Also known as: Aricept
Selegiline & low-dose donepezil
SelegilineDRUG

Transdermal selegiline, 6 mg daily

Also known as: EMSAM
Selegiline & high-dose donepezilSelegiline & low-dose donepezil
PlaceboDRUG

microcrystalline cellulose

Sugar pill

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV-TR criteria for cocaine abuse or dependence
  • At least one cocaine-positive urine within 6 weeks prior to enrollment
  • Has used cocaine for a duration of at least 6 months
  • At least weekly cocaine use during the last 30 days

You may not qualify if:

  • History of a medical adverse reaction to cocaine or other psychostimulants
  • Any current Axis I psychiatric disorder other than drug abuse or dependence
  • Dependence on abused substances other than cocaine
  • Current or past history of seizure disorder
  • Heart or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Related Publications (2)

  • 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: 19836169BACKGROUND

  • Grasing K, Yang Y, He S. Reversible and persistent decreases in cocaine self-administration after cholinesterase inhibition: different effects of donepezil and rivastigmine. Behav Pharmacol. 2011 Feb;22(1):58-70. doi: 10.1097/FBP.0b013e3283428cd8.

    PMID: 22173266BACKGROUND

MeSH Terms

Interventions

DonepezilSelegiline

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Substance Abuse Research Laboratory, Kansas City VA Medical Center

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 19, 2011

Study Start

February 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

US(1)