GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

NCT ID: NCT00089687

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.

Detailed Description

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Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

Conditions

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Cocaine-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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GBR 12909

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be within 20% of ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria for abuse or dependence on cocaine.
* Must be non-treatment seeking at the time of the study.

Exclusion Criteria

* Please contact the study site for more information.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Louis Cantilena, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of Health Science

Locations

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Uniformed Services University of Health Science

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CPU-0005-1

Identifier Type: -

Identifier Source: org_study_id

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