NCT00032916

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

January 11, 2017

Status Verified

April 1, 2004

First QC Date

April 5, 2002

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related DisordersDrug Administration ScheduleInfusions, Intravenous

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic parameter comparison

  • plasma concentration

Interventions

NS2359DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of Health Science

Bethesda, Maryland, 20814 4799, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

GSK372475

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Louis Cantilena, M.D.

    Uniformed Services University of Health Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 5, 2002

First Posted

April 8, 2002

Study Start

June 1, 2001

Study Completion

December 1, 2002

Last Updated

January 11, 2017

Record last verified: 2004-04

Locations

US(1)