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Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

Phase 4
18 Years
Not Enrolling
Smoking, Smoking Cessation

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Trial Information

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

The study design is a fully crossed 2x2x2 factorial design that tested the effect of two
versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy
(nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the
effect of cognitive medication adherence counseling (CMAC) versus no CMAC. A total of 987
smokers seeking cessation assistance from the Wisconsin Tobacco Quit Line (WTQL) were
randomly assigned to the eight (2x2x2) different conditions generated by the three
experimental factors. This design provides us with sufficient power to analyze each of our
three main effects listed above. We will also test for two- and three-way interactions, but
do not have sufficient data to make a priori assumptions about interaction effects.
Finally, we will conduct a cost-effectiveness analysis for each of the three interventions
to allow readers of this research to evaluate whether the additional costs of the
interventions yield sufficient gains to warrant implementing them broadly.

The only people eligible for this study are Wisconsin residents who contact the Wisconsin
Tobacco Quit Line for smoking cessation services.

Inclusion Criteria:

- Callers will be eligible to participate in the study if they are English speaking;
are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are
interested in quitting and are willing to set a quit date; willing and able to use
nicotine patch and nicotine gum; agree to receive four follow-up counseling calls
from Free & Clear (the quitline vendor for the State of Wisconsin); provide verbal
informed consent; and provide contact information and agree to take four study
follow-up calls from staff at the University of Wisconsin Center for Tobacco Research
and Intervention.

Exclusion Criteria:

- Callers will be excluded if they are under the age of 18; are pregnant or
breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are
unwilling or unable to use study NRT medications; are currently using a cessation
medication (NRT, bupropion, varenicline); or have medical exclusions as per
FDA-approved product labeling.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

7-Day Point Prevalence Abstinence From Smoking by Intervention

Outcome Description:

Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.

Outcome Time Frame:

26 weeks after the target quit smoking date

Safety Issue:


Principal Investigator

Stevens S Smith, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health


United States: Institutional Review Board

Study ID:




Start Date:

April 2010

Completion Date:

November 2011

Related Keywords:

  • Smoking
  • Smoking Cessation
  • Smoking
  • Smoking cessation
  • Medication adherence
  • Smoking



Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.) Seattle, Washington  98104
University of Wisconsin Center for Tobacco Research and Intervention Madison, Wisconsin  53711