Advancing Tobacco Use Treatment for African American Smokers

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, to characterize nicotine and
carcinogen exposure, 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.

Inclusion Criteria:

- Self-identified African American

- Smokes ≥ 1 cigarette per day (cpd)

- Smoke 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

- History of alcohol or drug dependence 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

- Evidence of current severe major depressive disorder or suicidal ideation