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A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics.

ABSTRACT: BACKGROUND:African-Americans smoke fewer cigarettes per day than Whites but experience greater smoking attributable morbidity and mortality. African-American-White differences may also exist in cessation but rigorously designed studies have not been conducted to empirically answer this question. METHODS/DESIGN:Quit2Live is, to our knowledge, the first head-to-head trial designed with the primary aim of examining African-American-White disparities in quitting smoking. Secondary aims are to identify mechanisms that mediate and/or moderate the relationship between race and quitting. The study is ongoing. Study aims are accomplished through a 5-year prospective cohort intervention study designed to recruit equal numbers of African-Americans (n=224) and Whites (n=224) stratified on age (<40, ?40) and gender, key factors known to impact cessation, and all within a restricted income range (?400% federal poverty level). All participants will receive 12 weeks of varenicline in combination with smoking cessation counseling. The primary outcome is cotinine-verified 7-day point prevalence abstinence from smoking at week 26. Secondary outcomes are cotinine-verified 7-day point prevalence abstinence from smoking at weeks 4 and 12. DISCUSSION:Findings from Quit2Live will not only address if African-American-White disparities in quitting smoking exist but, more importantly, will examine mechanisms underlying the difference. Attention to proximal, modifiable mechanisms (e.g., adherence, response to treatment, depression, stress) maximizes Quit2Live's potential to inform practice. Findings will provide an empirically-derived approach that will guide researchers and clinicians in identifying specific factors to address to improve cessation outcomes and reduce tobacco-related morbidity and mortality in African-American and White smokers. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT01836276.

SUBMITTER: Nollen NL

PROVIDER: S-EPMC4818177 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics.

Nollen Nicole L NL Cox Lisa Sanderson LS Yu Qing Q Ellerbeck Edward F EF Scheuermann Taneisha S TS Benowitz Neal L NL Tyndale Rachel F RF Mayo Matthew S MS Ahluwalia Jasjit S JS

Contemporary clinical trials 20151205

<h4>Background</h4>African-Americans smoke fewer cigarettes per day than Whites but experience greater smoking attributable morbidity and mortality. African-American-White differences may also exist in cessation but rigorously designed studies have not been conducted to empirically answer this question.<h4>Methods/design</h4>Quit2Live is, to our knowledge, the first head-to-head trial designed with the primary aim of examining African-American-White disparities in quitting smoking. Secondary aim ...[more]

PMID: 26667382

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Project description: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 (150 mg 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 16.4 ppm (range 1-55) and a mean serum cotinine of 275.8 ng/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.ClinicalTrials.gov: NCT00666978.

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A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics.

Publications

A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics.

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