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Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Primary Purpose

Tobacco Use Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

varenicline

nicotine patch

About this trial

This is an interventional prevention trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy 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:
- "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

Sites / Locations

Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (varenicline)

Arm II (nicotine patch)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01771627

First Posted

January 16, 2013

Last Updated

September 4, 2020

Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01771627

Brief Title

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 22, 2012 (Actual)

Primary Completion Date

September 28, 2014 (Actual)

Study Completion Date

August 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Roswell Park Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (varenicline)

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm II (nicotine patch)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

varenicline

Other Intervention Name(s)

Champix, Chantix, CP-526555

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

nicotine patch

Other Intervention Name(s)

NicoDerm CQ, nicotine skin patch, nicotine transdermal patch, nicotine transdermal system patch

Primary Outcome Measure Information:

Title

Quit Rate

Description

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.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Mahoney

Organizational Affiliation

Roswell Park Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

available upon request from PI

IPD Sharing Time Frame

now thru 2021

IPD Sharing Access Criteria

available upon request from PI

Citations:

Citation

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

Results Reference

background

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Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

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