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

Nicole L. Nollen, Lisa Sanderson Cox, Qing Yu, Edward F. Ellerbeck, Taneisha S. Scheuermann, Neal L. Benowitz, Rachel F. Tyndale, Matthew S. Mayo, Jasjit S. Ahluwalia

Research output: Contribution to journalArticlepeer-review

9 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)12-21
Number of pages10
JournalContemporary Clinical Trials
Volume47
DOIs
StatePublished - Mar 1 2016

Bibliographical note

Funding Information:
Research reported in this publication was supported by R01-DA031815 (N.L. Nollen) from the NIH, National Institute on Drug Abuse, Frontiers: The Heartland Institute for Clinical and Translational Research which is supported by a CTSA grant to the University of Kansas Medical Center from the NIH National Center for Advancing Translational Science ( NCATS ; grant # UL1TR000001 ), and by the National Cancer Institute Cancer Center Support Grant P30 CA168524 and used the Biospecimen Repository. The work was also supported by P50CA180890 (N.L. Benowitz) from the National Cancer Institute and the FDA Center for Tobacco Products, P30DA012393 (N.L. Benowitz) from the National Institute on Drug Abuse , and with instrumentation and analytical chemistry support from the National Institutes of Health, S10 RR026437. We acknowledge the support of the Endowed Chair in Addictions for the Department of Psychiatry (R.F. Tyndale), and CIHR grant TMH-109787 (R. F. Tyndale).

Keywords

  • African-American
  • Disparities
  • Smoking cessation
  • Varenicline
  • White

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