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About
This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking
Full description
PRIMARY OBJECTIVES:
I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers.
II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks.
ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
After completion of study treatment, patients are followed up at 4 months.
Enrollment
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Volunteers
Inclusion criteria
Cigarette smokers who call the New York State Smokers' Quitline requesting assistance with quitting smoking
State that they are under the care of a primary care physician
Are eligible for receipt of pharmacotherapy by mail using the standard NRT criteria
Speak English
Answer "no" to the following 3 questions:
Exclusion criteria
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Interventional model
Masking
300 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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