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

National Institute on Drug Abuse (NIDA)24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

NS2359DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Uniformed Services University of Health Science

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameter comparison

plasma concentration

Data from ClinicalTrials.gov

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