Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: varenicline; Drug: nicotine patch

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: varenicline; Given PO; Other Names: Champix; Chantix; CP-526555
Active Comparator: Arm II (nicotine patch); Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.	Drug: nicotine patch; Other Names: NicoDerm CQ; nicotine skin patch; nicotine transdermal patch; nicotine transdermal system patch

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2012
• Primary Completion (Actual): September 28, 2014
• Study Completion (Actual): August 28, 2015

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Varenicline
• Other Study ID Numbers: I 221312; NCI-2012-02755 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: available upon request from PI
• IPD Sharing Time Frame: now thru 2021
• IPD Sharing Access Criteria: available upon request from PI
• IPD Sharing Supporting Information Type: Study Protocol