Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

NCT ID: NCT01771627

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-22
• Study Completion Date: 2015-08-28

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm I (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.

Group Type: EXPERIMENTAL

varenicline

Intervention Type: DRUG

Given PO

Arm II (nicotine patch)

Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

Group Type: ACTIVE_COMPARATOR

nicotine patch

Intervention Type: DRUG

Interventions

varenicline

Given PO

Intervention Type: DRUG

nicotine patch

Intervention Type: DRUG

Other Intervention Names

Champix; Chantix; CP-526555; NicoDerm CQ; nicotine skin patch; nicotine transdermal patch; nicotine transdermal system patch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Mahoney

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

Rojewski AM, Hyland A, Mahoney MC. Cooper LM, Zuromski KL, Celestino P, Koutsky J, Toll BA. Feasibility of delivering varenicline through a telephone quitline to promote smoking cessation. J Smoking Cessation 2018

Reference Type: BACKGROUND

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

NCI-2012-02755

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 221312

Identifier Type: -

Identifier Source: org_study_id