Varenicline and Combined NRT for Smoking Cessation

Primary Objectives: To estimate (a) the effects at 12 weeks of either continuing on their current medication, switching to the other medication, or increasing the dose of their current medication among smokers initially treated with either varenicline 2 mg (VAR) or nicotine patch + ad lib lozenge (combined nicotine replacement therapy; CNRT) but who relapsed to smoking by week 6 of treatment, and (b) the effects of 12 weeks of continued treatment on either VAR or CNRT among individuals who are abstinent from smoking at 6 weeks. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive varenicline orally (PO) once daily (QD) or twice daily (BID), placebo patches QD, and placebo lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to CNRT, or receiving high-dose varenicline. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment. GROUP II: Patients receive placebo tablets PO QD or BID, nicotine patches QD, and nicotine lozenges PO QD beginning on day 9 and continue for 6 weeks. Patients who are abstinent at week 6 will continue treatment for an additional 6 weeks. Patients who fail to achieve abstinence at week 6 are re-randomized to 6 additional weeks of therapy consisting of either continuing on the same treatment, switching to varenicline, or receiving high-dose CNRT. Patients also receive behavioral smoking cessation counseling consisting of 4 in-person visits, 4 phone visits, and 4 brief supportive phone calls lasting 10-15 minutes each over the 12 weeks of treatment.