The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.
To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking \>10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluation of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco-related morbidity and mortality in this high-risk population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
University of Kansas Medical Center
Kansas City, Kansas, United States
Swope Health Central
Kansas City, Missouri, United States
Number of Participants With Smoking Abstinence at Month 6
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit
Time frame: Month 6
Number of Participants With Smoking Abstinence at Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit
Time frame: Week 12
Number of Participants With Smoking Abstinence at Week 26
Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment
Time frame: Week 26
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