Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Long-term NRT has not 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 see if guided maintenance therapy (GMT), using long-term NRT,
might prove to be a reasonable alternative to the standard approach of asking patients to
quit immediately. The investigators believe that GMT with long-term NRT will reduce overall
exposure to cigarette smoke, reduce harm related to smoking, and ultimately lead to greater
quit rates.
In this study, 398 smokers with COPD will be randomly assigned to either receive: 1)
traditional smoking cessation (SC) or 2) long-term, guided maintenance therapy with NRT
(GMT). The SC intervention will be based on a standard approach to smoking cessation,
including smoking cessation counseling supplemented with combination NRT (a nicotine patch
plus the patient's choice of gum or lozenge) if they are willing to make a quit attempt. The
GMT intervention will consist of counseling, focused on medication adherence and smoking
reduction, plus 52 weeks of combination NRT. After 3, 6 and 12 months of treatment, we will
compare the two treatments based on their effects on smoking cessation, number of cigarettes
smoked, exposure to carbon monoxide and smoking-related carcinogens, COPD symptoms, breathing
function, and smoking-related hospitalizations or death. The investigators will also analyze
the data in such a way that will be able to identify which patients are most likely to
benefit from treatment. This analysis will allow patients to estimate their chances of
success based on their own personal characteristics and which treatment they choose.
The investigators study addresses research priorities identified in recent smoking cessation
guidelines and builds upon the input of our Patient Advisory Panel and our Stakeholder
Advisory Committee. This study reflects the interests expressed by smokers in prior surveys
and addresses the limited reach and effectiveness of traditional approaches to smoking
cessation. If our GMT approach is effective, our study could change the recommendations
provided in clinical practice guidelines and change the way that insurance companies pay for
smoking cessation treatment. GMT could provide an alternative for millions of smokers with
COPD who are not currently benefiting from traditional approaches to smoking cessation