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Drug Interaction Study with NS2359 and Cocaine in Cocaine Experienced Volunteers - 1 - Article


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Drug Safety




Clinical Trial: Drug Interaction Study with NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

This study is no longer recruiting patients.

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)

Purpose

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

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

MedlinePlus related topics:  Cocaine Abuse

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

Official Title: Drug Interaction Study with NS2359 and Cocaine in Cocaine Experienced Volunteers

Further Study Details: 

Expected Total Enrollment:  24

Study start: June 2001;  Study completion: December 2002

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   -   45 Years,  Genders Eligible for Study:  Both

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.


Location Information


Maryland
      Uniformed Services University of Health Science, Bethesda,  Maryland,  20814 4799,  United States

Study chairs or principal investigators

Louis Cantilena, M.D.,  Principal Investigator,  Uniformed Services University of Health Science   

More Information

Study ID Numbers:  NIDA-CPU-2359-02-1
Record last reviewed:  April 2004
Last Updated:  February 16, 2005
Record first received:  April 5, 2002
ClinicalTrials.gov Identifier:  NCT00032916
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources

  • (National Women's Health Information Center, OWH, HHS)
  • (National Women's Health Information Center, OWH, HHS)


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Page Updated: September 6, 2005
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