title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01836276.
authors.affiliation: Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: nnollen@kumc.edu.
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Nollen
authors.affiliation: Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: lcox@kumc.edu.
authors.forename: Lisa Sanderson
authors.initials: LS
authors.lastname: Cox
authors.affiliation: Department of Biostatistics, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: qyu@kumc.edu.
authors.forename: Qing
authors.initials: Q
authors.lastname: Yu
authors.affiliation: Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: eellerbe@kumc.edu.
authors.forename: Edward F
authors.initials: EF
authors.lastname: Ellerbeck
authors.affiliation: Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: tscheuermann@kumc.edu.
authors.forename: Taneisha S
authors.initials: TS
authors.lastname: Scheuermann
authors.affiliation: Division of Clinical Pharmacology and Experimental Therapeutics, University of California, San Francisco, San Francisco, California, United States; Department of Medicine, University of California, San Francisco, San Francisco, California, United States; Department of Bioengineering, University of California, San Francisco, San Francisco, California, United States; Department of Therapeutic Sciences, University of California, San Francisco, San Francisco, California, United States. Electronic address: neal.benowitz@ucsf.edu.
authors.forename: Neal L
authors.initials: NL
authors.lastname: Benowitz
authors.affiliation: Center for Addiction and Mental Health, University of Toronto, Toronto, Ontario, Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada; Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada. Electronic address: r.tyndale@utoronto.ca.
authors.forename: Rachel F
authors.initials: RF
authors.lastname: Tyndale
authors.affiliation: Department of Biostatistics, University of Kansas School of Medicine, Kansas City, Kansas, United States. Electronic address: mmayo@kumc.edu.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Mayo
authors.affiliation: Department of Epidemiology, Rutgers School of Public Health, Piscataway, New Jersey, United States. Electronic address: j.ahluwalia@rutgers.edu.
authors.forename: Jasjit S
authors.initials: JS
authors.lastname: Ahluwalia
mesh_terms: D000328:Adult; D001741:Black or African American; D015331:Cohort Studies; D003376:Counseling; D005260:Female; D054624:Health Status Disparities; D006801:Humans; D008297:Male; D018722:Nicotinic Agonists / Q000627:therapeutic use*; D011446:Prospective Studies; D012907:Smoking / Q000628:therapy*; D016540:Smoking Cessation / Q000208:ethnology* / Q000379:methods; D014029:Tobacco Use Disorder / Q000628:therapy*; D016896:Treatment Outcome; D000068580:Varenicline / Q000627:therapeutic use*; D044465:White People
chemical_list: D018722:Nicotinic Agonists; D000068580:Varenicline
keywords: African-American; Disparities; Smoking cessation; Varenicline; White