Clinical trial NCT01771627: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Quit Rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Martin Mahoney
role: PRINCIPAL_INVESTIGATOR
References:
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