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NCT00051896 Clinical Trial

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
Secondary ID
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
Est. completion date
Est. primary completion date
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

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
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