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

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

October 23, 2007

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic parameter comparison
plasma concentration

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00032916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Brief Summary

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

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control

Condition ^ICMJE

Cocaine-Related Disorders
Drug Administration Schedule
Infusions, Intravenous

Intervention ^ICMJE

Drug: NS2359

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

December 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00032916

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CPU-2359-02-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP