Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
NCT01087905 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 987
Last updated 2016-12-08
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.
Conditions
- Smoking
- Smoking Cessation
Interventions
- DRUG
-
Nicotine patch
If \> 10 cigs/day: one 21 mg nicotine patch per day If \< or = 10 cigs/day: one 14 mg nicotine patch per day
- DRUG
-
Nicotine gum
If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
- BEHAVIORAL
-
CMAC
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Sponsors & Collaborators
-
Wisconsin Department of Health and Family Services
collaborator OTHER_GOV -
Consumer Wellness Solutions
collaborator INDUSTRY -
Department of Health and Human Services
collaborator FED -
National Cancer Institute (NCI)
collaborator NIH -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Stevens S Smith, PhD · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
-
Paula A Keller, MPH · University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-04-30
- Primary Completion
- 2011-02-28
- Completion
- 2011-11-30
Countries
- United States
Study Locations
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