NCT00089687

Brief Summary

The purpose of this study is to assess GBR 12909 in cocaine experienced African American 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
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2005

First QC Date

August 10, 2004

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic assessment

Interventions

GBR 12909DRUG

Eligibility Criteria

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

You may qualify if:

  • Must be within 20% of ideal body weight and must weigh at least 45 kg.
  • Must understand the study procedures and provide written informed consent.
  • Must meet DSM-4 criteria for abuse or dependence on cocaine.
  • Must be non-treatment seeking at the time of the study.

You may not qualify if:

  • Please contact the study site for more information.

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

vanoxerine

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
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 10, 2004

First Posted

August 11, 2004

Study Start

April 1, 2004

Study Completion

May 1, 2005

Last Updated

January 11, 2017

Record last verified: 2005-01

Locations

US(1)