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Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 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
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00051896
First received: January 17, 2003
Last updated: April 25, 2012
Last verified: March 2005
  Purpose
The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

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

Study Type: Interventional
Study Design: Masking: Double-Blind
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

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

Primary Outcome Measures:
  • Pharmacokinetic parameter comparison

Estimated Enrollment: 24
Study Start Date: August 2002
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.
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier: NCT00051896

Locations
United States, Maryland
Uniformed Services University of Health Science
Bethesda, Maryland, United States, 20814 4799
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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 
Study First Received: January 17, 2003
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Vanoxerine
Anesthetics, Local
Anesthetics
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

ClinicalTrials.gov processed this record on December 02, 2016