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

NCT ID: NCT00032916

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2002-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Drug Administration Schedule Infusions, Intravenous

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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NS2359

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Louis Cantilena, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of Health Science

Locations

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Uniformed Services University of Health Science

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CPU-2359-02-1

Identifier Type: -

Identifier Source: org_study_id

NCT00031330

Identifier Type: -

Identifier Source: nct_alias

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