Phase 4
N=987
Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Smoking · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01087905 ↗Enrolled (actual)
987
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: 7-Day Point Prevalence Abstinence From Smoking by Intervention — 43.3; 48.9; 42.3; 49.9 Percentage of participants not smoking — p=.076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nicotine patch (Drug); Nicotine gum (Drug); CMAC (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-Day Point Prevalence Abstinence From Smoking by Intervention |
43.3; 48.9; 42.3; 49.9; 47.6; 44.6 | .076 |
| PRIMARY 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group |
38.4; 48.2; 46.2; 51.6 | .029 sig |
| SECONDARY Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group |
94; 118; 115; 128 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01087905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.