Advancing Tobacco Use Treatment for African American Smokers

Study Overview
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Brief Summary
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The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

Detailed Description
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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.

Official Title
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Advancing Tobacco Use Treatment for African American Smokers

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Chantix
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chantix (varenicline)<br>Participants will receive 1mg pills to take twice a day for 12 weeks. | Drug: Chantix<br>* A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.<br>* Other names: Varenicline;|
| Placebo Comparator: Placebo<br>Participants will receive a placebo pill to take twice a day for 12 weeks. | Drug: Placebo<br>* Health education counseling will be provided to all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, quit smoking, smoking treatment