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

Cocaine-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00051896
• Other study ID #: NIDA-CPU-0002-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 17, 2003
• Last updated: January 10, 2017
• Start date: August 2002

Study information

• Verified date: March 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 the potential interactions between iv cocaine and GBR 12909.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Masking: Double-Blind, 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 parameter comparison