Results Summary
What was the research about?
Chronic obstructive pulmonary disease, or COPD, is a lung disease that makes it hard to breathe. People with COPD who smoke may find it very hard to quit smoking.
The research team compared two ways to help people with COPD quit cigarette smoking. The first way was long-term nicotine replacement therapy, or LT-NRT. This therapy lets people slowly cut back on their smoking by using nicotine patches, gum, and lozenges while they continue to smoke. The second way was standard smoking cessation, or SSC. Counselors help people who smoke pick a date to quit and prepare for it. People may then use nicotine patches, lozenges, and gum on or after that quit date. The team wanted to see if LT-NRT was better than SSC at helping patients with COPD quit smoking.
What were the results?
After one year, the research team didn’t find a difference between the two groups in the number of people who had stopped smoking. The study also found no differences between the groups in the number of cigarettes smoked per day, the number of times patients tried to quit smoking, and the amount of unhealthy chemicals they breathed in. There were no differences in how well their lungs worked or in how many times they had to go to the hospital or emergency room.
In this study, the research team found that patients in the SSC group took less time to complete the program and had fewer side effects than those in the LT-NRT group.
Who was in the study?
The study included 398 adult patients who had COPD, spoke English or Spanish, and smoked five or more cigarettes per day. The patients were from two medical centers in the Midwest. Of these patients, 60 percent were women. In addition, 70 percent were white, 28 percent were African American, and 2 percent were other races. The average age was 56.
What did the research team do?
The research team assigned patients with COPD to one of two groups by chance. One group got LT-NRT to help them quit smoking; the other group got SSC. In the LT-NRT group, patients received a combination of nicotine patches and nicotine gum or lozenges for 12 months as well as information about how to use them at an in-person counseling session. Patients in this group also received calls from trained counselors to see if they were using the patches, gum, and lozenges. The counselors also asked patients about side effects and helped patients decide if they were getting enough nicotine to satisfy cravings. Patients had six follow-up counseling sessions.
Patients in the SSC group had counseling sessions by phone on coping skills and stress management when quitting smoking. The counselors helped patients who said they were ready to quit smoking create a plan for quitting. If they set a quit date, patients got nicotine patches and nicotine gum or lozenges to use on the day they chose to quit smoking and for the next 10 weeks.
After one year, the research team compared the number of patients who had stopped smoking in each group.
The research team asked people from organizations that help smokers quit, former and current smokers who have COPD, doctors, and public health experts to help guide the study.
What were the limits of the study?
Some patients in the SSC group used nicotine patches and nicotine gum or lozenges, even though they didn’t set a quit date. This nicotine use by the SSC group may have made it more difficult for the study team to see if there were differences in quitting smoking between the two groups.
How can people use the results?
Both LT-NRT and the SSC helped some patients with COPD quit smoking. SSC may be the better choice for patients with COPD who are ready to quit because it had fewer side effects and took less time to complete than LT-NRT.
Professional Abstract
Objective
To determine whether long-term nicotine replacement therapy (LT-NRT) leads to greater quit rates compared with standard smoking cessation (SSC) in people with chronic obstructive pulmonary disease (COPD) who smoke
Study Design
Design Elements | Description |
---|---|
Design | Randomized controlled trial |
Population | 398 adults with COPD who smoked 5 or more cigarettes per day and spoke English or Spanish |
Interventions/ Comparators |
|
Outcomes |
Primary: biochemically verified 7-day smoking abstinence at 12 months Secondary: biochemically verified 7-day smoking abstinence at 6 months, 6-month sustained abstinence, number of quit attempts over 12 months, average number of cigarettes smoked per day over 12 months, exposure to carbon monoxide over 12 months, exposure to carcinogens over 12 months, respiratory function, respiratory symptoms, respiratory-related hospitalizations, ED visits |
Timeframe | 3-, 6-, and 12-month follow-up for primary outcome |
The research team conducted a randomized controlled trial to test the effectiveness of LT-NRT compared with SSC in achieving smoking abstinence in people with COPD. LT-NRT lets people slowly cut back on the number of cigarettes they smoke by using nicotine patches, gum, and lozenges. With SSC, counselors help people pick a date to quit smoking and prepare for it. Counselors then provide nicotine patches, lozenges, and gum for patients to use on or after that quit date for up to 10 weeks.
The research team included a patient advisory board of former and current smokers with COPD and a stakeholder advisory board with representatives of smoking-cessation organizations, healthcare providers, and public health experts.
The team recruited 398 patients from two medical centers in the Midwest. Of these patients, 60% of participants were female, 70% were white, and 29% were African American. The mean patient age was 56.
Participants in the LT-NRT arm of the study received a combination of nicotine patches and nicotine gum and lozenges to use right away and over the 12-month study period. The participants also received instructions on how to use them at an in-person counseling session. They received calls from trained counselors to assess usage, side effects, and adequacy of nicotine receipt. Patients had six follow-up counseling sessions in person and by phone over 12 months.
Participants in the SSC arm received an in-person counseling session on coping skills and stress management, as well as a plan for smoking cessation if they felt they were ready to quit. They also received follow-up sessions by phone at 1, 3, 6, and 10 weeks after starting.
Participants in both arms received written educational materials about quitting smoking. The research team collected data on outcomes during in-person assessments at enrollment and 3, 6, and 12 months later.
Results
- Self-reported smoking abstinence at 3, 6, and 12 months was not significantly different between the LT-NRT group and the SSC group (12.2% versus 11.7%, respectively, at 12 months).
- There were no significant differences between the LT-NRT and SSC groups in the number of quit attempts, number of cigarettes smoked per day, exposure to carbon monoxide, exposure to carcinogens, respiratory function, respiratory symptoms, and respiratory hospitalizations or emergency department visits.
- SSC had a shorter duration of treatment and fewer side effects compared with LT-NRT.
Limitations
In this study, 15% of the SSC group reported ongoing use of NRT at 12 months whereas 39% of those in the LT-NRT group had stopped using NRT at 12 months. This may have limited the team’s ability to measure differences in outcomes between the two groups.
Conclusions and Relevance
LT-NRT did not improve smoking abstinence or reduce smoking-related harm more effectively than SSC. In this study, the research team found that SSC had a shorter duration of treatment and fewer side effects. Therefore, it may be the better choice for patients with COPD who are ready to quit smoking.
Future Research Needs
Future research could look at the benefits of other types of smoking cessation pharmacotherapy or alternative nicotine delivery devices, such as e-cigarettes. Future research could also look at engaging patients in a greater number of quit attempts.
Final Research Report
View this project's final research report.
Journal Citations
Article Highlight: Among smokers with chronic obstructive pulmonary disease (COPD), the number who quit after receiving 23 months of nicotine-replacement therapy (NRT) and six counseling sessions was nearly the same as the number who quit after receiving 10 weeks of NRT and four counseling sessions, according to findings of this study published in JAMA Network Open. While there were insignificant differences in the number of cigarettes smoked per day between the groups, both saw decreases in exposure to unhealthy chemicals and adverse cardiac events. The study followed nearly 400 adults.
Results of This Project
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, the PI made changes including
- Adding information in the abstract and limitations that the study could not identify and assess participant subgroups because there were such low rates of smoking cessation overall
- Clarifying how both the intervention and comparison conditions were meant to help smokers quit smoking, but that the intervention approach was more gradual, focused on reducing smoking first until the smoker could quit
- Providing more information about the sensitivity analyses conducted as part of the study. The investigators chose to count any patients missing outcome data as continued smokers, which led to more conservative but essentially the same results as the prespecified analyses
- Revised language in the study conclusions to accurately reflect that the data did not clearly show a faster response in either group over time, because the results of time by group interaction tests did not reach statistical significance