Back to resultsGBR 12909 Study in Cocaine Experienced African American Volunteers - 1
Primary Purpose
Cocaine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GBR 12909
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
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.
Sites / Locations
- Uniformed Services University of Health Science
Outcomes
Primary Outcome Measures
pharmacokinetic assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT00089687
First Posted
August 10, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00089687
Brief Title
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1
Official Title
GBR 12909 Study in Cocaine Experienced African American Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess GBR 12909 in cocaine experienced African American Volunteers.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GBR 12909
Primary Outcome Measure Information:
Title
pharmacokinetic assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Cantilena, M.D.
Organizational Affiliation
Uniformed Services University of Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of Health Science
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814 4799
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GBR 12909 Study in Cocaine Experienced African American Volunteers - 1
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