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Open Access 01-12-2010 | Research article

Design, recruitment, and retention of African-American smokers in a pharmacokinetic study

Authors: Babalola Faseru, Lisa S Cox, Carrie A Bronars, Isaac Opole, Gregory A Reed, Matthew S Mayo, Jasjit S Ahluwalia, Kolawole S Okuyemi

Published in: BMC Medical Research Methodology | Issue 1/2010

Abstract

Background

African-Americans remain underrepresented in clinical research despite experiencing a higher burden of disease compared to all other ethnic groups in the United States. The purpose of this article is to describe the study design and discuss strategies used to recruit and retain African-American smokers in a pharmacokinetic study.

Methods

The parent study was designed to evaluate the differences in the steady-state concentrations of bupropion and its three principal metabolites between African-American menthol and non-menthol cigarette smokers. Study participation consisted of four visits at a General Clinical Research Center (GCRC) over six weeks. After meeting telephone eligibility requirements, phone-eligible participants underwent additional screening during the first two GCRC visits. The last two visits (pharmacokinetic study phase) required repeated blood draws using an intravenous catheter over the course of 12 hours.

Results

Five hundred and fifteen African-American smokers completed telephone screening; 187 were phone-eligible and 92 were scheduled for the first GCRC visit. Of the 81 who attended the first visit, 48 individuals were enrolled in the pharmacokinetic study, and a total of 40 individuals completed the study (83% retention rate).

Conclusions

Although recruitment of African-American smokers into a non-treatment, pharmacokinetic study poses challenges, retention is feasible. The results provide valuable information for investigators embarking on non-treatment laboratory-based studies among minority populations.

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2288/10/6/prepub

Title: Design, recruitment, and retention of African-American smokers in a pharmacokinetic study
Authors: Babalola Faseru
Lisa S Cox
Carrie A Bronars
Isaac Opole
Gregory A Reed
Matthew S Mayo
Jasjit S Ahluwalia
Kolawole S Okuyemi
Publication date: 01-12-2010
Publisher: BioMed Central
Published in: BMC Medical Research Methodology / Issue 1/2010
Electronic ISSN: 1471-2288
DOI: https://doi.org/10.1186/1471-2288-10-6

At a glance: The STEP trials

Springer Medicine

Design, recruitment, and retention of African-American smokers in a pharmacokinetic study

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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