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Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 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:
NCT00100113
First received: December 22, 2004
Last updated: October 23, 2007
Last verified: March 2005
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of Interactions Between GBR 12909 and Cocaine

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Heart rate

Estimated Enrollment: 24
Study Start Date: June 2004
Estimated Study Completion Date: June 2005
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.

  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% 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100113

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

No publications provided

ClinicalTrials.gov Identifier: NCT00100113     History of Changes
Other Study ID Numbers: NIDA-CPU-0004-1
Study First Received: December 22, 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 19, 2013