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GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00089687
First received: August 10, 2004
Last updated: October 23, 2007
Last verified: January 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
 Drug: GBR 12909
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: GBR 12909 Study in Cocaine Experienced African American Volunteers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • pharmacokinetic assessment

Estimated Enrollment: 10
Study Start Date: April 2004
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089687

Locations
United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00089687     History of Changes
Other Study ID Numbers: NIDA-CPU-0005-1
Study First Received: August 10, 2004
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Vanoxerine
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013