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Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01771627
First received: January 16, 2013
Last updated: November 5, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Tobacco Use Disorder
Drug: varenicline
Drug: nicotine patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Quit rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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.

  • Incremental cost per quit [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]
    Will be calculated by comparing the quit rates between the 2 conditions.


Estimated Enrollment: 300
Study Start Date: October 2012
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771627

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Martin Mahoney Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01771627     History of Changes
Other Study ID Numbers: I 221312, NCI-2012-02755
Study First Received: January 16, 2013
Last Updated: November 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Varenicline
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014