Design, recruitment, and retention of African-American smokers in a pharmacokinetic study.
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.
Faseru
Babalola
B
Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS, USA. bfaseru@kumc.edu
Cox
Lisa S
LS
Bronars
Carrie A
CA
Opole
Isaac
I
Reed
Gregory A
GA
Mayo
Matthew S
MS
Ahluwalia
Jasjit S
JS
Okuyemi
Kolawole S
KS
D001741:Black or African American / Q000523:psychology; D016642:Bupropion / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D008610:Menthol; D008722:Methods; D033281:Nontherapeutic Human Experimentation; D010342:Patient Acceptance of Health Care / Q000208:ethnology*; D018579:Patient Selection; D012107:Research Design; D012907:Smoking / Q000378:metabolism*
D016642:Bupropion; D008610:Menthol