Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

This study is ongoing, but not recruiting participants.

First Received: April 5, 2002 Last Updated: October 23, 2007 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00032916

Purpose

The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

Condition	Intervention	Phase
Cocaine-Related Disorders Drug Administration Schedule Infusions, Intravenous	Drug: NS2359	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride NS 2359

U.S. FDA Resources

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

Primary Outcome Measures:

Pharmacokinetic parameter comparison
plasma concentration

Estimated Enrollment:	24
Study Start Date:	June 2001
Estimated Study Completion Date:	December 2002

Detailed Description:

This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse.

Exclusion Criteria:

Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032916

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-2359-02-1
Study First Received:	April 5, 2002
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00032916 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Disorders of Environmental Origin
Cardiovascular Agents
Anesthetics, Local

Pharmacologic Actions
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Cocaine
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009