Understanding Disparities in Quitting in African American and White Smokers

While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.

Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.

• Experimental: African American (AA) Smokers
  AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
  Intervention: Drug: Varenicline
• Active Comparator: White Smokers
  White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
  Intervention: Drug: Varenicline

• Peng AR, Swardfager W, Benowitz NL, Ahluwalia JS, Lerman C, Nollen NL, Tyndale RF. Impact of early nausea on varenicline adherence and smoking cessation. Addiction. 2020 Jan;115(1):134-144. doi: 10.1111/add.14810. Epub 2019 Nov 5.
• Nollen NL, Mayo MS, Sanderson Cox L, Benowitz NL, Tyndale RF, Ellerbeck EF, Scheuermann TS, Ahluwalia JS. Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study. J Natl Cancer Inst. 2019 Oct 1;111(10):1078-1087. doi: 10.1093/jnci/djz001.
• Nollen NL, Cox LS, Yu Q, Ellerbeck EF, Scheuermann TS, Benowitz NL, Tyndale RF, Mayo MS, Ahluwalia JS. A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2016 Mar;47:12-21. doi: 10.1016/j.cct.2015.12.001. Epub 2015 Dec 5.

Inclusion Criteria:

• Non-Hispanic African American or non-Hispanic White
• ? 18 years of age
• Smoked 3-20 cigarettes per day
• Smoked on >25 days of the past 30 days
• Functioning telephone
• Interested in quitting smoking
• Interested in taking 3 months of varenicline
• Willing to complete all study visits

Exclusion Criteria:

• Renal impairment
• Evidence or history of clinically significant allergic reactions to varenicline

• A cardiovascular event in the past month Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:

  • Angina
  • Myocardial infarction
  • Peripheral vascular disease
  • Stroke
• New onset of chest pain or arrhythmia in the past 2 months
• History of alcohol or drug dependency in the past year
• Major depressive disorder in the last year requiring treatment
• History of panic disorder, psychosis, bipolar disorder, or eating disorders
• Use of tobacco products other than cigarettes in past 30 days
• Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
• Pregnant, contemplating getting pregnant, or breastfeeding
• Plans to move from Kansas City during the treatment and follow-up phase
• Another household member enrolled in the study

• National Institute on Drug Abuse (NIDA)
• Pfizer