Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 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

First Received on January 17, 2003. Last Updated on October 25, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00051896

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 I

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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Vanoxerine Gbr 12909

U.S. FDA Resources

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
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

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00051896 History of Changes
Other Study ID Numbers:	NIDA-CPU-0002-1
Study First Received:	January 17, 2003
Last Updated:	October 25, 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 February 12, 2012