Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data
1 Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS, USA
2 Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, USA
3 Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA
4 Program in Health Disparities Research, University of Minnesota Medical School, Minneapolis, MN, USA
5 University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
6 Division of Clinical Pharmacology and Experimental Therapeutics, Department of Medicine and Bioengineering & Therapeutic Sciences, University of California, San Francisco, CA USA
7 Center for Addiction and Mental Health and Departments of Psychiatry and Pharmacology, University of Toronto, Toronto, ON, Canada
8 Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, USA
9 Center for Health Equity, University of Minnesota Medical School, Minnespolis, MN, USA
Trials 2011, 12:22 doi:10.1186/1745-6215-12-22Published: 25 January 2011
African Americans experience significant tobacco-related health disparities despite the fact that over half of African American smokers are light smokers (use ≤10 cigarettes per day). African Americans have been under-represented in smoking cessation research, and few studies have evaluated treatment for light smokers. This paper describes the study design, measures, and baseline characteristics from Kick It at Swope III (KIS-III), the first treatment study of bupropion for African American light smokers.
Five hundred forty African American light smokers were randomly assigned to receive bupropion (150mg bid) (n = 270) or placebo (n = 270) for 7 weeks. All participants received written materials and health education counseling. Participants responded to survey items and provided blood samples for evaluation of phenotype and genotype of CYP2A6 and CYP2B6 enzymes involved in nicotine and bupropion metabolism. Primary outcome was cotinine-verified 7-day point prevalence smoking abstinence at Week 26 follow-up.
Of 2,628 individuals screened, 540 were eligible, consented, and randomized to treatment. Participants had a mean age of 46.5 years and 66.1% were women. Participants smoked an average of 8.0 cigarettes per day, had a mean exhaled carbon monoxide of 16.4ppm (range 1-55) and a mean serum cotinine of 275.8ng/ml. The mean Fagerström Test for Nicotine Dependence was 3.2, and 72.2% of participants smoked within 30 minutes of waking. The average number of quit attempts in the past year was 3.7 and 24.2% reported using pharmacotherapy in their most recent quit attempt. Motivation and confidence to quit were high.
KIS-III is the first study designed to examine both nicotine and bupropion metabolism, evaluating CYP2A6 and CYP2B6 phenotype and genotype in conjunction with psychosocial factors, in the context of treatment of African American light smokers. Of 1629 smokers screened for study participation, only 18 (1.1%) were ineligible to participate in the study because they refused blood draws, demonstrating the feasibility of recruiting and enrolling African American light smokers into a clinical treatment trial involving biological data collection and genetic analyses. Future evaluation of individual factors associated with treatment outcome will contribute to advancing tailored tobacco use treatment with the goal of enhancing treatment and reducing health disparities for African American light smokers.