NCT00697138

Brief Summary

Cocaine dependence is a significant public health concern. The proposed research will provide important clinical information regarding the efficacy of agonists replacement therapies for managing cocaine dependence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_1

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

June 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 1, 2012

Status Verified

February 1, 2012

Enrollment Period

5.6 years

First QC Date

June 11, 2008

Last Update Submit

February 29, 2012

Conditions

Cocaine Dependence

Keywords

CocaineDependencePharmacotherapies

Outcome Measures

Primary Outcomes (1)

  • Behavioral effects of cocaine

    Measure throughout the study

Secondary Outcomes (1)

  • Heart rate; blood pressure; ECG

    Measure throughtout study

Study Arms (1)

A

EXPERIMENTAL
Drug: d-Amphetamine; Atomoxetine

Interventions

d-Amphetamine; AtomoxetineDRUG

Dexedrine (0-60 mg/day); Strattera (0-80 mg/day)

A

Eligibility Criteria

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

You may qualify if:

  • Must meet diagnostic criteria for cocaine dependence Current cocaine use at study entry, as determined by urine screen Body Mass Index less or equal to 30 ECG results within normal limits If female, willing to use contraception throughout study

You may not qualify if:

  • Meets diagnostic criteria for dependence on drug other than cocaine and nicotine Currently seeking treatment for substance abuse Current or past history of serious illness including impaired heart function, seizures and central nervous system tumors Family history o heart disease or seizures Current of past psychiatric disorder other than substance abuse Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536 0086, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

DextroamphetamineAtomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsPropylamines

Study Officials

  • Craig R Rush, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princpal Investigator

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 1, 2012

Record last verified: 2012-02

Locations

US(1)