Overview

This trial is active, not recruiting.

Condition cocaine-related disorders
Treatment gbr 12909
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Start date April 2004
End date May 2005
Trial size 10 participants
Trial identifier NCT00089687, NIDA-CPU-0005-1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
pharmacokinetic assessment
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

Official title GBR 12909 Study in Cocaine Experienced African American Volunteers
Principal investigator Louis Cantilena, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).