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Assessment of Potential Interactions Between GBR 12909 and Cocaine - 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 March 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: December 22, 2004
Last updated: January 10, 2017
Last verified: March 2005
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:

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00100113     History of Changes
Other Study ID Numbers: NIDA-CPU-0004-1
Study First Received: December 22, 2004
Last Updated: January 10, 2017

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 processed this record on September 19, 2017