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.

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.

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

Conflict of Interest Disclosures

Project Information

Edward Ellerbeck, MD, MPH
University of Kansas Medical Center
$2,134,842
10.25302/12.2018.AD.130603104
Smoking Cessation Versus Long-Term Nicotine Replacement among High-Risk Smokers

Key Dates

December 2013
March 2018
2013
2018

Study Registration Information

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Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022