Understanding Disparities in Quitting in African American and White Smokers

Study Overview
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Brief Summary
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The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.

Detailed Description
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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.

Official Title
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Understanding Disparities in Quitting in African American and White Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: African American (AA) Smokers<br>AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. | Drug: Varenicline<br>* 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines<br>* Other names: Chantix®;|
| Active Comparator: White Smokers<br>White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions. | Drug: Varenicline<br>* 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines<br>* Other names: Chantix®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26 | Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers. | Change from Baseline to Week 26 |