Overview

This trial is active, not recruiting.

Conditions cocaine-related disorders, drug administration schedule, infusions, intravenous
Treatment ns2359
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Start date June 2001
End date December 2002
Trial size 24 participants
Trial identifier NCT00032916, NCT00031330, NIDA-CPU-2359-02-1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Pharmacokinetic parameter comparison
time frame:
plasma concentration
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers
Principal investigator Louis Cantilena, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).