This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.
Cigarette smoking is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States and accounts for 30% of U.S. cancer deaths. Varenicline and bupropion SR (sustained-release) are non nicotine pharmacotherapies FDA-indicated for the treatment of tobacco dependence in cigarette smokers. Although varenicline has proven greater efficacy than bupropion SR, both medications are associated with high end-of-treatment smoking abstinence rates. However, almost two-thirds of smokers treated with varenicline report smoking at 6 months. Because varenicline and bupropion SR have different mechanisms of action and different neuropharmacologic targets, combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy. In our recent pilot study of combination therapy with varenicline and bupropion SR, we observed treatment to be well-tolerated with 7-day point prevalence smoking abstinence rates of 71% (95% CI: 54-85%) at 3 months and 58% (95% CI: 41-74%) at 6 months. Determining the efficacy of combination therapy compared to single-agent therapy has immediate and important clinical implications. In this study, we will conduct a randomized, multicenter, controlled clinical trial evaluating the efficacy of combination therapy with varenicline and bupropion SR compared to varenicline and placebo in 506 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
506
varenicline - 1 mg bid for 12 weeks
placebo for 12 weeks
bupropion sr - 150 mg bid for 12 weeks
University Of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Franciscan Skemp Hospital
La Crosse, Wisconsin, United States
Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.
Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Time frame: 3 months
Point Prevalence Abstinence at 3 Months.
biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.
Time frame: 3 months
Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.
Time frame: 6 months
Weight Gain From Baseline to 3 Months
Weight change from baseline to three months in those who met criteria for prolonged abstinence at the 3 month visit
Time frame: 3 months
Point Prevalence Abstinence at 6 Months.
Biochemically confirmed abstinence as no smoking, even a puff, for the prior 7 days.
Time frame: 6 months
Prolonged Abstinence at 12 Months
Time frame: 12 months
Point Prevalence Abstinence at 12 Months
Biochemically confirmed abstinence defined as no smoking, not even a puff, in the last 7 days
Time frame: 12 months
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