A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers
Condition: Smoking Cessation; Smoking; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Nicotine lozenge; Nicotine Patch
Intervention description: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.; Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.; Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1086.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Smoking; Nicotine

Summary:

      The overall purpose of this research is two-fold. First, the two smoking cessation medication
      treatments with the strongest evidence of effectiveness have never been directly compared.
      This research will determine how these two treatments compare in effectiveness in a
      head-to-head trial, and which types of smokers benefit most from each. Second, much of the
      data on smoking and health come from studies from many years ago. Today's smokers differ from
      earlier smokers in many ways that could influence the impact of smoking on health (e.g.,
      weight, sex, diet, socio-economic status); the proposed work will determine how smoking
      cessation affects cardiovascular and pulmonary health in today's smokers.
    

Eligibility criteria:

        We are only recruiting by invitation only (to members of our past cohort). We will open up
        enrollment to the public in the Madison, WI and Milwaukee WI areas at the end of 2012.

        Inclusion Criteria:

        a. To be eligible for the Comparative effectiveness trial, participants must:

          -  smoke 5 or more cigarettes per day,

          -  desire to quit smoking but not be currently engaged in cessation treatment,

          -  be medically eligible to use either combination NRT or varenicline,

          -  have reliable phone access,

          -  if female, must not be pregnant and must be willing to use an acceptable birth control
             method.

        Exclusion Criteria:

          1. There are no exclusion criteria for participating in the main health outcomes study,
             other than being unwilling to complete study assessments.

          2. All smoking participants from new and original cohorts will be excluded from the
             cessation trial for the following reasons:

               -  end-stage renal disease with hemodialysis;

               -  prior suicide attempts within the last 5 years or current suicidal ideation;

               -  diagnosis of and/or treatment for schizophrenia;

               -  other psychotic disorders or bipolar disorder within the last 10 years;

               -  current PHQ-9 score indicative of moderately severe depression;

               -  severe untreated hypertension >200/100 mmHg;

               -  currently taking Wellbutrin, Zyban or bupropion;

               -  hospitalized for a stroke, heart attack, congestive heart failure or diabetes
                  within the last year;

               -  used pipe tobacco, cigars, snuff or chew more than twice in the past week.

        It should be noted that if any incidental findings appear in any of the cardiology tests
        (e.g., ultrasound, tonometry, ECG, or exercise stress test; see forms in Supplemental
        Information section of application), the study cardiologist (Dr. Stein or his designee)
        will be assign the participant to the non-randomized treatment arm and they will be given
        the nicotine patch and the same counseling intervention as CET participants. They will not
        be included in the CET analyses. This will be done to properly address the cardiovascular
        risk warning from the FDA regarding varenicline (Chantix).