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Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

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ClinicalTrials.gov Identifier: NCT00051896
Recruitment Status : Unknown
Verified March 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2003
Last Update Posted : January 11, 2017
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: GBR 12909 Phase 1

Detailed Description:
This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers
Study Start Date : August 2002
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Pharmacokinetic parameter comparison

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must understand study procedures and provide written informed consent
  • For additional inclusion criteria information, please contact study site for more information.

Exclusion Criteria:

  • Please contact study site for more information.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051896

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

ClinicalTrials.gov Identifier: NCT00051896     History of Changes
Other Study ID Numbers: NIDA-CPU-0002-1
First Posted: January 20, 2003    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: March 2005

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