Cigarette smoking promotes atherosclerosclerotic cardiovascular disease (ASCVD), and cessation confers significant health benefits to patients with heart disease. Total abstinence is the goal of current tobacco dependence treatment models, however, it is not accessible to many patients. There is a strong dose-response relationship between the amount smoked and risk for ASCVD, suggesting that for those patients who cannot stop, reducing smoking may be of benefit. Nicotine replacement therapy (NRT) is safe in patients with cardiovascular disease, and limited data suggest that long term NRT is effective at reducing tobacco use and carbon monoxide (CO) exposure. We propose a randomized controlled clinical trial in 180 patients with ASCVD to test the hypothesis that a combined behavioral and pharmacological intervention designed to reduce smoking by at least 50% will 1) reduce cigarette consumption, 2) improve smoking cessation rates, 3) reduce signs and symptoms of ASCVD, 4) improve risk factors for ASCVD, and 5) prove to be cost-effective in terms of cost per quality adjusted life year gained. We will randomly assign subjects from two ambulatory care sites to the smoking reduction treatment (SR) group (including a standardized approach to transdermal nicotine, or nicotine gum if not successful reducing using patch) or the control group. Subjects will be followed for a two year period, and will be encouraged to quit at any time if they are ready. We will collect data regarding smoking behavior, exercise tolerance, angina, quality of life, and adverse events; and measure nicotine, cotinine, CO, lipids, and fibrinogen. We will contribute samples to the Biomarker Core project to assess the effect of smoking reduction on other toxin levels. We will conduct an economic analysis of the potential cost-effectiveness of this approach. This study will test whether a long term strategy to reduce cigarette consumption in a medically ill population is safe, effective , and improves health outcomes for smokers who cannot quit.
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