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.
Professional Abstract
Objective
To compare the effectiveness of nicotine replacement therapy (NRT) plus tobacco cessation counseling versus tobacco cessation counseling alone in increasing smoking abstinence among African-American adults who were non-daily smokers
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 278 African-American adults who were non-daily smokers reporting cigarette use on 4–27 days in the past month and willing to try to quit smoking within 2 weeks of study start |
| Interventions/ Comparators |
|
| Outcomes |
Primary: biochemically verified abstinence from smoking at week 12 Secondary: biochemically verified abstinence from smoking at week 26, nicotine exposure and carcinogen exposure, self-reported days abstinent, cigarettes smoked, and use of non-cigarette tobacco products |
| Timeframe | 12-week follow-up for primary outcome |
Compared with non-Hispanic white adults, adults from racial and ethnic minority groups are more likely to be non-daily smokers. African Americans who are non-daily smokers have a higher risk of cardiovascular disease and cancer than other racial and ethnic minority groups. This randomized controlled trial compared NRT plus tobacco cessation counseling versus tobacco cessation counseling alone among African Americans who were non-daily smokers.
The research team randomly assigned participants to one of two groups: NRT plus counseling or counseling alone. In both groups, a counselor met individually with participants during the first week of the study and then by phone at 1, 4, 8, and 10 weeks. The phone sessions used a protocol tailored for African Americans that was designed to increase knowledge about the benefits of smoking cessation and help develop behavioral and cognitive skills to promote cessation. Participants in both groups set a quit date for two weeks after the start of the study. In one group, participants also received their choice of NRT, including nicotine gum, patches, or lozenges.
The study included 278 African-American adults who reported smoking cigarettes on 4–27 days in the past 30 days. All received study-related care at a federally qualified health center in Kansas City, Missouri. The average age of participants was 49, and 51% were female.
At weeks 4, 8, and 12, participants answered questions about their tobacco use in the past 30 days. They reported the number of cigarettes smoked, use of non-cigarette tobacco products, and the number of days they did not use tobacco. At 12 and 26 weeks, the research team collected urine samples to check if people had quit smoking and measure exposure to nicotine and a chemical carcinogen found in tobacco.
Adults who were non-daily smokers, physicians, and tobacco quitline staff advised on the research questions, intervention design, and study outcomes.
Results
Participants in the two groups did not differ significantly in biochemically verified smoking abstinence at weeks 12 or 26. At 12 weeks, abstinence rates were 9% for participants who received counseling alone and 11% for participants who received counseling and NRT. At 26 weeks, abstinence rates were 7% in both groups.
Compared with participants who received counseling alone, participants who also received NRT reported more days abstinent (p<0.001) and fewer total cigarettes used (p=0.002) in the past 30 days. The two groups did not differ in carcinogen exposure, nicotine exposure, or use of non-cigarette tobacco products.
Limitations
Overall, NRT adherence ranged from 60% to 105% of recommended doses taken depending on type of NRT at their highest; adherence was lowest from weeks 8–12, with 27–63% of recommended doses taken. Low NRT adherence may have affected the study results.
Conclusions and Relevance
In this study, NRT plus tobacco cessation counseling did not improve smoking cessation more than cessation counseling alone. However, compared with participants who only received counseling, those who also received NRT reported more days abstinent and fewer cigarettes used in the past 30 days.
Future Research Needs
Future research could focus on more intensive treatments than NRT with higher rates of adherence, like bupropion, varenicline, or combination NRT for African-American non-daily smokers.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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.