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Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

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ClinicalTrials.gov Identifier: NCT00100113
Recruitment Status : Unknown
Verified March 2005 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2004
Last Update Posted : January 11, 2017
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

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

Detailed Description:
This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: Study of Interactions Between GBR 12909 and Cocaine
Study Start Date : June 2004
Estimated Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Heart rate

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:   Yes

Inclusion Criteria:

  • Must be within 20% 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 and are non-treatment seeking at time of study.

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): NCT00100113

United States, Texas
U of Texas Medical Branch Galveston
Galveston, Texas, United States, 77555 1031
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kathryn Cunningham, Ph.D. University of Texas Medical Branch - Galveston
More Information

ClinicalTrials.gov Identifier: NCT00100113     History of Changes
Other Study ID Numbers: NIDA-CPU-0004-1
First Posted: December 23, 2004    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: March 2005

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

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