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 bupropion SR and varenicline compared to varenicline and placebo in 450 cigarette smokers at the Mayo Clinic in Rochester, MN, and the University of Minnesota in Minneapolis, MN.

Public Health Relevance

Cigarette smoking kills an estimated 480,000 people in the United States each year. Despite the best therapies, almost two-thirds of patients go back to smoking by 6 months. Combining medications together may increase the long-term smoking quit rates and decrease the death and disability associated with cigarette smoking.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA138417-04
Application #
8250457
Study Section
Risk, Prevention and Intervention for Addictions Study Section (RPIA)
Program Officer
Morgan, Glen D
Project Start
2009-05-01
Project End
2014-04-30
Budget Start
2012-05-01
Budget End
2014-04-30
Support Year
4
Fiscal Year
2012
Total Cost
$490,083
Indirect Cost
$119,267
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
Hong, Arthur S; Elrashidi, Muhamad Y; Schroeder, Darrell R et al. (2015) Depressive symptoms among patients receiving varenicline and bupropion for smoking cessation. J Subst Abuse Treat 52:78-81
Ebbert, Jon O; Hatsukami, Dorothy K; Croghan, Ivana T et al. (2014) Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA 311:155-63