Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Condition: Smoking; Smoking Cessation
Intervention: Nicotine patch; Nicotine gum; CMAC
Intervention description: If > 10 cigs/day: one 21 mg nicotine patch per day
If < or = 10 cigs/day: one 14 mg nicotine patch per day; 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.; 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 987.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking; Smoking cessation; Medication adherence

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.