A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Nicotine; Varenicline

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).