A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Completed · Phase 4

Conditions studied: Smoking Cessation, Smoking, Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01553084

Run by

University of Wisconsin, Madison

People needed

1086

Starts

2012-05-01

Expected to finish

2017-08-01

Last updated by the study team

2020-09-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria for participating in the main health outcomes study, other than being unwilling to complete study assessments.
• 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).

Where it is running

• University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health — Madison, Wisconsin, United States
• University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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