GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

GBR 12909 Study in Cocaine Experienced African American Volunteers

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814 4799
        • Uniformed Services University of Health Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
pharmacokinetic assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Louis Cantilena, M.D., Uniformed Services University of Health Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

August 10, 2004

First Submitted That Met QC Criteria

August 10, 2004

First Posted (Estimate)

August 11, 2004

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CPU-0005-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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