Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: nicotine patch; Drug: varenicline

• Registration Number: NCT01771627
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10-22
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2014-09-28
• Study Completion: 2015-08-28
• Status Verified: 2020-09
• Results First Submitted: 2020-09-04
• Results First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Results First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (nicotine patch)	nicotine patch	Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
Arm I (varenicline)	varenicline	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.

Primary Outcome Measures

Name	Time	Method
Quit Rate	4 months	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States