Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

This study is ongoing, but not recruiting participants.

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

Sponsored by:	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

Drug Information available for: Vanoxerine Gbr 12909

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Dose Comparison
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
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

Study ID Numbers:	NIDA-CPU-0002-1
Study First Received:	January 17, 2003
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00051896 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Vanoxerine
Neurotransmitter Agents
Dopamine

Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Dopamine Agents
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Cocaine-Related Disorders
Vanoxerine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Mental Disorders
Physiological Effects of Drugs
Substance-Related Disorders
Disorders of Environmental Origin
Dopamine Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009