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GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: August 10, 2004
Last updated: January 10, 2017
Last verified: January 2005
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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00089687

United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science
  More Information Identifier: NCT00089687     History of Changes
Other Study ID Numbers: NIDA-CPU-0005-1
Study First Received: August 10, 2004
Last Updated: January 10, 2017

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on April 28, 2017