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NCT00032916 Clinical Trial

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

Cocaine-Related Disorders Clinical Trial

Official title:
Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00032916
Other study ID # NIDA-CPU-2359-02-1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received April 5, 2002
Last updated January 10, 2017
Start date June 2001
Est. completion date December 2002

Study information
Verified date April 2004
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers
  • NCT00031330

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date December 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NS2359

Locations
Country Name City State
United States Uniformed Services University of Health Science Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameter comparison
Primary plasma concentration
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