Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

NCT01771627 | Completed Results

• 2 other identifiers: I 221312NCI-2012-02755
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I (varenicline)

EXPERIMENTAL

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

Arm II (nicotine patch)

ACTIVE COMPARATOR

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

Drug: nicotine patch

Interventions

varenicline DRUG

Given PO

Also known as: Champix, Chantix, CP-526555

Arm I (varenicline)

nicotine patch DRUG

Also known as: NicoDerm CQ, nicotine skin patch, nicotine transdermal patch, nicotine transdermal system patch

Arm II (nicotine patch)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (2)

• 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

  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.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics; Solanaceous Alkaloids; Alkaloids; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Ben Toll
• Organization: MUSC

toll@musc.edu

843-792-9162

Study Officials

• Martin Mahoney

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: October 22, 2012
• Primary Completion: September 28, 2014
• Study Completion: August 28, 2015
• Last Updated: September 28, 2020
• Results First Posted: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: now thru 2021
• Access Criteria: available upon request from PI

Locations

US (1)