Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Drug: varenicline
* Drug: nicotine patch


Participation Criteria
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Eligibility Criteria
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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: Have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder? Have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself? Is there any reason that you cannot use varenicline/Chantix? Exclusion Criteria: State that they are not under the care of a primary care physician Are not eligible for receipt of pharmacotherapy by mail using the standard NRT criteria Do not speak English Answer yes to the question, have you ever been diagnosed with or treated for a mental health problem like major depression, bipolar disorder, dysthymia, or schizoaffective disorder? Answer yes to the question, have you ever had serious thoughts of killing or hurting yourself, ever have any intention or plan to carry out these thoughts, or actually attempted to kill yourself? Answer yes to the question, is there any reason that you cannot use varenicline/Chantix? Are women who are currently pregnant Report that they are unwilling to receive or take varenicline on screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (varenicline)<br>Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. | Drug: varenicline<br>* Given PO<br>* Other names: CP-526555;|
| Active Comparator: Arm II (nicotine patch)<br>Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks. | Drug: nicotine patch<br> <br> * Other names: nicotine transdermal system patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Rate | The quit rate at 4 months will be compared between the 2 groups, using a logistic regression analysis with a 2-side 95% confidence interval. | 4 months |