Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Smoking Cessation, Smoking Cessation, Pulmonary, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/8/2017 |
| Start Date: | May 2014 |
| End Date: | December 2016 |
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
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
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
1. Compare the benefits of traditional smoking cessation (SC) versus guided maintenance
therapy (GMT) with NRT for smokers with COPD.
2. 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.
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
1. Compare the benefits of traditional smoking cessation (SC) versus guided maintenance
therapy (GMT) with NRT for smokers with COPD.
2. 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
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