Varenicline and Combined NRT for Smoking Cessation

Inclusion Criteria: * Smoking 5 or more cigarettes, little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm) (if less than or equal to 5, then positive cotinine test) * Interested in treatment that might change smoking behavior * Able to follow verbal and written instructions in English and complete all aspects of the study * Provide informed consent and agree to all assessments and study procedures * Have an address and telephone number where he/she may be reached * Be the only participant in his/her household Exclusion Criteria: * Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study * Current enrollment or plans to enroll in another smoking cessation program in the next 12 months * Plan to use other nicotine substitutes (i.e., over-the-counter \[OTC\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months * Uncontrolled hypertension (systolic blood pressure; \[SBP\] greater than 180 or diastolic blood pressure; \[DBP\] greater than 110) * History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liv…