Results Summary

What was the research about?

People who smoke tobacco are at higher than average risk for cancer, heart disease, and other health problems, even if they are non-daily smokers. Compared with non-daily smokers in other racial and ethnic groups, African Americans who are non-daily smokers have even higher risks of heart disease and cancer.

In this study, the research team looked at two ways to help African-American adults who were non-daily smokers quit smoking. One way included counseling plus nicotine replacement therapy, or NRT. NRT includes nicotine gum, patches, or lozenges to help control nicotine cravings. The team compared people who had counseling and NRT with people who had only counseling.

What were the results?

The percent of people who quit smoking didn’t differ much between the two groups.

  • After 12 weeks, 11 percent of those who had NRT and counseling and 9 percent of those who had only counseling had quit smoking.
  • After 26 weeks, 7 percent of people in each group had quit.

People who had NRT and counseling reported more days without smoking and fewer total cigarettes used in the past month than those who only had counseling.

The two groups also didn’t differ in

  • Exposure to nicotine or a chemical found in tobacco that causes cancer
  • Use of other tobacco products, such as chewing tobacco

Who was in the study?

The study included 278 African-American adults who reported smoking cigarettes between 4 and 27 days in the past month. The average age was 49, and 51 percent were women. All attended a clinic that serves people with low incomes in Kansas City, Missouri.

What did the research team do?

The research team assigned people by chance to one of two groups: NRT plus counseling or counseling only. In both groups, people set a quit date for two weeks from the start of the study. They first met one-on-one with a counselor. Then at 1, 4, 8, and 10 weeks, they had counseling sessions by phone. Tailored for African-American communities, the sessions aimed to

  • Increase knowledge about the risks of non-daily smoking and the benefits of quitting smoking
  • Promote skills to help quit smoking

In one group, people also received their choice of NRT, including nicotine gum, patches, or lozenges.

At 4, 8, and 12 weeks, people reported the number of cigarettes they smoked and other tobacco products used in the past month. They also reported how many days in the past month they didn’t use tobacco. At 12 and 26 weeks, the research team checked if people had quit smoking. They collected urine samples to measure exposure to nicotine and the cancer-causing chemical.

Adults who were non-daily smokers, doctors, and tobacco quitline staff advised on the study.

What were the limits of the study?

On average, people took less NRT than recommended. Results may have differed if people used NRT at the recommended dose.

People may be more likely to use some forms of NRT, like the nicotine patch. Future research could focus on these treatments.

How can people use the results?

People helping African-American adults who are non-daily smokers quit smoking can use the results.

Final Research Report

View this project's final research report.

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 assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot 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 descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers said the study overemphasized a significant result, that the addition of nicotine-replacement therapy (NRT) to counseling increased abstinence and reduced cigarette use, without putting that result in the context of the non-significant results. That is, these secondary outcomes showed significant differences between the intervention groups at one time point, but those differences were not significant over time. Also, there was no evidence that one intervention group improved more over time than the other. The researchers rewrote the abstract, discussion, and conclusions to better put these results into context and in particular, group these results with other secondary outcomes rather than highlighting them out of order.
  • The reviewers observed that the participants in this project differed from non-daily smokers (NDS) in other studies. The ones in this study tended to smoke more days per month and were more likely to have repeatedly and recently failed to quit smoking. Reviewers noted that the fact that the study did not detect a statistically significant treatment effect might reflect having a population that found quitting smoking harder than the average NDS population. The researchers agreed that these are important points and rewrote the discussion section to address how their sample differed from previous samples of African-American NDS.
  • The reviewers expressed concern about the internal validity of the intervention because of the low and variable participant adherence with the NRT intervention. They asked the researchers to include additional discussion of how this variable adherence might affect the reproducibility and interpretation of study findings. The researchers disagreed that adherence rates were a problem for internal validity, given that participants were explicitly allowed to switch or discontinue NRT treatment. The researchers did address the low NRT adherence among study participants in several places in the report.

Conflict of Interest Disclosures

Project Information

Nikki Nollen, PhD
University of Kansas Medical Center Research Institute, Inc.
$2,074,491 *
10.25302/08.2020.AD.131008709
Informing Tobacco-Treatment Guidelines for African American Non-Daily Smokers

Key Dates

July 2014
December 2019
2014
2019

Study Registration Information

Final Research Report

View this project's final research report.

Journal Articles

Tags

Has Results
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
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Funding Opportunity Type
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
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: November 30, 2022