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

Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00032916
Enrollment
24
Registered
2002-04-08
Start date
2001-06-30
Completion date
2002-12-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGNS2359

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameter comparison—
plasma concentration—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026