Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

January 17, 2003

Last Updated Date

October 25, 2007

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic parameter comparison

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00051896 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

Official Title ^ICMJE

Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers

Brief Summary

The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

Detailed Description

This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Dose Comparison

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: GBR 12909

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must understand study procedures and provide written informed consent
For additional inclusion criteria information, please contact study site for more information.

Exclusion Criteria:

Please contact study site for more information.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00051896

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CPU-0002-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Louis Cantilena, M.D.

Uniformed Services University of Health Science

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP