GBR 12909 Study in Cocaine Experienced African American Volunteers - 1

Cocaine-Related Disorders Clinical Trial

Official title:

GBR 12909 Study in Cocaine Experienced African American Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00089687
• Other study ID #: NIDA-CPU-0005-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: August 10, 2004
• Last updated: January 10, 2017
• Start date: April 2004
• Est. completion date: May 2005

Study information

• Verified date: January 2005
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers. Particular interest is being given to the hematological safety data.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Please contact the study site for more information.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• GBR 12909

Locations

Country	Name	City	State
United States	Uniformed Services University of Health Science	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic assessment