NCT00100113

Brief Summary

The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

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 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

June 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

January 11, 2017

Status Verified

March 1, 2005

First QC Date

December 22, 2004

Last Update Submit

January 10, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • Heart rate

Interventions

GBR 12909DRUG

Eligibility Criteria

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

You may qualify if:

  • Must be within 20% 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 and are non-treatment seeking at time of study.

You may not qualify if:

  • Please contact study site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U of Texas Medical Branch Galveston

Galveston, Texas, 77555 1031, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

vanoxerine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kathryn Cunningham, Ph.D.

    University of Texas Medical Branch - Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

June 1, 2004

Study Completion

June 1, 2005

Last Updated

January 11, 2017

Record last verified: 2005-03

Locations

US(1)