Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers

BACKGROUND Smokers with chronic obstructive pulmonary disease (COPD) recognize the dangers of continued smoking and would like to quit, but for most of them the idea of going 'cold turkey' is too intimidating. Many of these smokers would like to cut back on the amount that they smoke as part of a longer term path to quitting. Long-term nicotine replacement therapy (NRT) might allow them to do this. Long-term NRT is safe; it can reduce the rewarding effects of cigarettes, reduce the amount that people smoke, and increase quit rates. Long-term NRT has not, however, been studied in patients with COPD, and smokers in the United States with COPD are still asked to choose between immediate quitting or continued smoking. The purpose of this study is to evaluate the relative benefits of a third option: guided maintenance therapy with long-term NRT. We believe that long-term NRT could reduce overall exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater quit rates.

OBJECTIVES

• Compare the benefits of traditional smoking cessation (SC) versus guided maintenance therapy (GMT) with NRT for smokers with COPD.
• Estimate rates of smoking cessation and other patient-desired outcomes based on patient-specific characteristics and treatment choice (SC or GMT).

METHODS In this study, we will randomize 398 smokers with COPD to one of two treatment arms: 1) traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT (GMT). Participants in the SC arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with combination NRT (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Participants in the GMT arm will receive counseling focused on medication adherence and smoking reduction plus 52 weeks of combined NRT. Outcomes will be measured at 3, 6 and 12 months post-randomization and will assess rates of smoking cessation, number of cigarettes smoked, exposure to carbon monoxide and smoking-related carcinogens, and clinical outcomes including respiratory symptoms, respiratory function, and smoking-related hospitalizations or death. In addition to directly comparing outcomes in the two treatment arms, our novel classification and regression tree analysis will allow us to identify subgroups of patients most likely to benefit from treatment and will allow patients to estimate their projected outcomes given their personal history and their choice of therapy.

PATIENT OUTCOMES (PROJECTED) This study will show how long-term NRT compares to a traditional smoking cessation program in helping smokers quit, reduce cigarette exposure, lower exposure to carcinogens, and reduce risk for death and hospitalizations. If our hypothesis is correct, this program could dramatically alter treatment choices for the millions of smokers in the United States with COPD that have been frustrated in their attempts to quit.

Inclusion criteria

• 18 years of age or older
• Physician-diagnosed COPD
• Smoke 5 or more cigarettes/day
• Smoke cigarettes on 25 or more of the last 30 days
• Speak either English or Spanish
• Willing to take nicotine replacement therapy for up to 1 year and participate in study procedures

Exclusion criteria

• Reside in a facility that does not allow smoking
• Don't have an address and telephone
• Unstable cardiac condition (e.g. unstable angina or myocardial infarction in the past 30 days)
• Pregnant or breastfeeding
• Terminal illness with less than 12 month life expectancy