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.
Bibliographical noteFunding Information:
The authors would like to thank Michelle Boyd, Qingjiang Hou, Tricia Snow, Dawn Dillinger, Diana Stewart, Jean Sunega, and the KUMC GCRC Staff for their efforts on this project. We are grateful to the volunteers who participated in this study. This work was performed at the University of Kansas Medical Center, Kansas City, Kansas, with support from the National Institute on Drug Abuse (R21 DA 018720) and National Cancer Institute (R01 CA091912). KUMC GCRC is funded by the National Center for Research Resources (M01 RR0239410). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.