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


N/A
18 Years
N/A
Open (Enrolling)
Both
Tobacco Use Disorder

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Quit rate

Outcome Description:

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.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Martin Mahoney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 221312

NCT ID:

NCT01771627

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Tobacco Use Disorder
  • Tobacco Use Disorder

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263