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

Primary Purpose

Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NS2359

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Uniformed Services University of Health Science

Outcomes

Primary Outcome Measures

Pharmacokinetic parameter comparison

plasma concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT00032916

First Posted

April 5, 2002

Last Updated

January 10, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00032916

Brief Title

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

Official Title

Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2004

Overall Recruitment Status

Unknown status

Study Start Date

June 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

Double

Allocation

Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

NS2359

Primary Outcome Measure Information:

Title

Pharmacokinetic parameter comparison

Title

plasma concentration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis Cantilena, M.D.

Organizational Affiliation

Uniformed Services University of Health Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uniformed Services University of Health Science

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20814 4799

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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