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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00032916
First received: April 5, 2002
Last updated: October 23, 2007
Last verified: April 2004
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Louis Cantilena, M.D. Uniformed Services University of Health Science
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00032916     History of Changes
Obsolete Identifiers: NCT00031330
Other Study ID Numbers: NIDA-CPU-2359-02-1
Study First Received: April 5, 2002
Last Updated: October 23, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014