Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771627
• Other study ID #: I 221312
• Secondary ID: NCI-2012-02755
• Status: Completed
• Phase: N/A
• Start date: October 22, 2012
• Est. completion date: August 28, 2015

Study information

• Verified date: September 2020
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 28, 2015
• Est. primary completion date: September 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• varenicline
Given PO
• nicotine patch

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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