Clinical trial NCT01087905: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Official title: Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Smoking Cessation
Keywords: Smoking
Smoking cessation
Medication adherence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Wisconsin Department of Health and Family Services
name: Consumer Wellness Solutions
name: Department of Health and Human Services
name: National Cancer Institute (NCI)
First posted: 2010-03-16
Enrollment: 987
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 7-Day Point Prevalence Abstinence From Smoking by Intervention
timeFrame: 26 weeks after the target quit smoking date
measure: 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
timeFrame: 26 weeks after the target quit smoking date
Secondary outcomes:
measure: Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
timeFrame: 26 weeks after the target quit smoking date
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Stevens S Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
name: Paula A Keller, MPH
role: STUDY_DIRECTOR
References:
citation: Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res. 2013 Mar;15(3):718-28. doi: 10.1093/ntr/nts186. Epub 2012 Sep 19.