MedPath

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

Phase 1
Conditions
Cocaine-Related Disorders
Drug Administration Schedule
Infusions, Intravenous
Registration Number
NCT00032916
Lead Sponsor
National Institute on Drug Abuse (NIDA)
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
24
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

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pharmacokinetic parameter comparison
plasma concentration
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Uniformed Services University of Health Science

🇺🇸

Bethesda, Maryland, United States

© Copyright 2025. All Rights Reserved by MedPath