NCT00032916UnknownPhase 1
Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers
National Institute on Drug Abuse (NIDA)1 site in 1 country24 target enrollmentStarted: June 1, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic parameter comparison
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Pharmacokinetic parameter comparison
plasma concentration
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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