Continued smoking by head and neck cancer patients is associated with poor survival, a greater risk of disease recurrence and a second primary tumor, reduced treatment efficacy, and adverse treatment-related complications. Nevertheless, 25-35 percent of patients who smoked prior to the diagnosis continue to do so following treatment. To date, rigorous studies of smoking cessation interventions for cancer patients have yet to be conducted. Since the presence of significant depressive symptoms - which can impede successful quitting - are common among cancer patients, it may be particularly important to address negative affect within a cessation program for this population using an antidepressant (i.e., bupropion). However, in light of barriers to bupropion use, including cost and adverse side effects, discerning subgroups of smokers in need of intensive (i.e., use of pharmacologic treatments, in addition to counseling and nicotine replacement therapy [NRT]) vs. moderate (i.e., involving counseling and NRT alone) treatments has become a priority in the field of nicotine addiction research. The presence vs. the absence of significant depressive symptoms may be a useful way for matching smokers to optimal treatments (i.e., depressed smokers may require bupropion in addition to counseling and NRT, whereas non-depressed smokers may be able to achieve cessation with NRT and counseling alone). Further, the mechanism through which bupropion affects smoking behavior has yet to be clearly delineated, although it may be through bupropion's influence on affect. Thus, this placebo-controlled randomized trial with 366 head and neck cancer patients will: 1) Compare intensive smoking cessation treatment (i.e., bupropion, NRT, counseling) to moderate smoking cessation treatment (i.e., placebo, NRT, counseling) for increasing quit rates among head and neck cancer patients (Aim 1);2) Determine whether the presence of significant depressive symptoms moderate the effect of bupropion on quit rates (Aim 2); and 3) Explore whether the effect of bupropion on smoking cessation is mediated by changes in positive or negative affect (Aim 3). The primary outcome for this study will be continuous abstinence, assessed using the time-line follow-back method, from the quit day until the 2-, 6-, and 12-month follow-up assessments. Overall, data from this study may guide the use of bupropion for treating nicotine addiction among head and neck cancer patients. In particular, our results may provide a guide for matching intensive vs. moderate cessation interventions according to the psychological needs of the cancer patient. Further, understanding the role of changes in affect as the mechanism that underlies the effects of bupropion may help to refine mood management clinical approaches for cancer patients. In turn, our findings may help guide the implementation of smoking cessation treatments for all cancer patients within Comprehensive Cancer Centers in the US.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
7R01CA095678-05
Application #
7178434
Study Section
Special Emphasis Panel (ZRG1-RPHB-2 (01))
Program Officer
Morgan, Glen D
Project Start
2002-06-01
Project End
2007-05-31
Budget Start
2005-09-13
Budget End
2006-05-31
Support Year
5
Fiscal Year
2005
Total Cost
$402,377
Indirect Cost
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Schnoll, Robert A; Martinez, Elisa; Langer, Corey et al. (2011) Predictors of smoking cessation among cancer patients enrolled in a smoking cessation program. Acta Oncol 50:678-84
Schnoll, Robert A; Martinez, Elisa; Tatum, Kristina L et al. (2010) A bupropion smoking cessation clinical trial for cancer patients. Cancer Causes Control 21:811-20
Martinez, Elisa; Tatum, Kristina L; Weber, Dorothy M et al. (2009) Issues related to implementing a smoking cessation clinical trial for cancer patients. Cancer Causes Control 20:97-104
Schnoll, Robert A; Patterson, Freda (2009) Sex heterogeneity in pharmacogenetic smoking cessation clinical trials. Drug Alcohol Depend 104 Suppl 1:S94-9
Schnoll, Robert A; Epstein, Leonard; Audrain, Janet et al. (2008) Can the blind see? Participant guess about treatment arm assignment may influence outcome in a clinical trial of bupropion for smoking cessation. J Subst Abuse Treat 34:234-41
Schnoll, Robert A; Johnson, Terrance A; Lerman, Caryn (2007) Genetics and smoking behavior. Curr Psychiatry Rep 9:349-57
Schnoll, Robert A; Patterson, Freda; Lerman, Caryn (2007) Treating tobacco dependence in women. J Womens Health (Larchmt) 16:1211-8
Schnoll, Robert A; Engstrom, Paul F; Subramanian, Somasundaram et al. (2006) Smoking cessation counseling by Russian oncologists: opportunities for intervention in the Russian Federation. Int J Behav Med 13:8-15
Schnoll, Robert A; Lerman, Caryn (2006) Current and emerging pharmacotherapies for treating tobacco dependence. Expert Opin Emerg Drugs 11:429-44
Schnoll, Robert A; Engstrom, Paul F; Subramanian, Somasundaram et al. (2006) Prevalence and correlates of tobacco use among Russian cancer patients: implications for the development of smoking cessation interventions at a cancer center in Russia. Int J Behav Med 13:16-25

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