Nicotine replacement therapy for smoking cessation has become a popular mode of treatment with the advent of nicotine gum and, more recently, transdermal nicotine (patch). Largely because of ease of compliance and an improved adverse-effect profile, transdermal nicotine has become the preferred method for pharmacological therapy. Whereas numerous clinical trials have demonstrated the efficacy of the patch relative to a placebo, the level of intensity of adjuvant counseling to achieve an acceptable rate of cessation remains uncertain. The investigators propose a study involving 1,900 smokers to be recruited to a randomized five-group design involving different combinations of transdermal nicotine plus usual care, telephone based counseling, or group-based counseling. Study participants will be followed for 13 months to determine a treatment outcome. Because treatment efficiency cannot be completely addressed without consideration of patient-treatment interactions and adequate valuations of the different treatment alternatives, the investigators also propose to use analytic methods from clinical medicine and pharmacoeconomics (cost-effectiveness analysis) to focus on these aspects of the overall research question. This study will be conducted in collaboration with the nation's largest health maintenance organization, Kaiser Permanente Medical Care Plan (KPMCP) of Northern California.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA071358-01A1
Application #
2009992
Study Section
Special Emphasis Panel (ZRG2-SSP (01))
Project Start
1997-01-03
Project End
2000-12-31
Budget Start
1997-01-03
Budget End
1997-12-31
Support Year
1
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Sri International
Department
Type
DUNS #
City
Menlo Park
State
CA
Country
United States
Zip Code
94025
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McClure, Jennifer B; Swan, Gary E; St John, Jackie et al. (2013) Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study. Nicotine Tob Res 15:518-26
Bergen, Andrew W; Javitz, Harold S; Krasnow, Ruth et al. (2013) Nicotinic acetylcholine receptor variation and response to smoking cessation therapies. Pharmacogenet Genomics 23:94-103
Swan, G E; Javitz, H S; Jack, L M et al. (2012) Varenicline for smoking cessation: nausea severity and variation in nicotinic receptor genes. Pharmacogenomics J 12:349-58
Javitz, Harold S; Zbikowski, Susan M; Deprey, Mona et al. (2011) Cost-effectiveness of varenicline and three different behavioral treatment formats for smoking cessation. Transl Behav Med 1:182-190
Catz, Sheryl L; Jack, Lisa M; McClure, Jennifer B et al. (2011) Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res 13:361-8
Zbikowski, Susan M; Jack, Lisa M; McClure, Jennifer B et al. (2011) Utilization of services in a randomized trial testing phone- and web-based interventions for smoking cessation. Nicotine Tob Res 13:319-27
Wessel, Jennifer; McDonald, Sarah M; Hinds, David A et al. (2010) Resequencing of nicotinic acetylcholine receptor genes and association of common and rare variants with the Fagerström test for nicotine dependence. Neuropsychopharmacology 35:2392-402
McClure, Jennifer B; Swan, Gary E; Catz, Sheryl L et al. (2010) Smoking outcome by psychiatric history after behavioral and varenicline treatment. J Subst Abuse Treat 38:394-402

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