Warning Labels on Cigarillo Packages for Smoking

Overseen By Jennifer Ross, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how different warning labels on cigarillo packages influence users' smoking habits and intentions. Participants will join one of three groups, each exposed to different types of warnings: pictorial images, FDA text-only warnings, or Surgeon General text-only warnings. Over four weeks, the study involves sorting cigarillo packages into flavor categories. The trial seeks current cigarillo users who smoke at least once a week. As an unphased trial, it offers participants the chance to contribute to significant research that may impact public health policies on smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe?

Research shows that picture warnings on tobacco products, such as cigarillos, are generally accepted by users. Studies have found that these warnings can increase the likelihood of wanting to quit smoking and lead to more frequent quit attempts. No evidence suggests that viewing these images causes any health problems.

Text-only warnings from the FDA or Surgeon General are also common on tobacco products and have not been known to cause harm. They aim to inform users about the dangers of smoking.

In summary, these warnings, whether pictorial or text-based, are designed to encourage quitting without harming the viewer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these warning labels on cigarillo packages because they offer a fresh approach to discouraging smoking. Unlike traditional text-only warnings, pictorial warnings use vivid images to convey the dangers of smoking, potentially making a stronger impact on consumers. The study also explores the effectiveness of different types of text-only warnings, comparing those from the FDA and the Surgeon General, which may provide insights into which messages resonate most with smokers. This trial could lead to more effective packaging strategies that better communicate health risks and encourage smoking cessation.

What evidence suggests that this trial's warning labels could be effective for reducing cigarillo smoking?

Research shows that picture warnings on cigarillo packages can be very effective. Participants in the pictorial warnings arm of this trial will view these types of warnings. A study that analyzed various research found that picture warnings outperformed text-only warnings in 12 out of 17 measures. Additionally, picture warnings tend to capture attention more effectively and increase the desire to quit smoking. In one study, similar picture warnings on cigarette packages led to a 4% drop in smoking rates in the first year. These findings suggest that picture warnings might provoke stronger reactions and encourage quitting more than text-only warnings, which participants in the FDA text-only warnings and Surgeon General text-only warnings arms will view. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer Ross, PhD

Principal Investigator

School of Public Health - Health Law Policy & Management Dept

Are You a Good Fit for This Trial?

This study is for current cigarillo smokers who have used cigarillos at least once a week in the past month. Participants will be recruited through Qualtrics Research Services.

Inclusion Criteria

Current cigarillo user-used cigarillos at least one time per week in the past month

Recruited through Qualtrics Research Services

Exclusion Criteria

Not recruited through Qualtrics Research Services

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants participate in an image-sorting task for 4 weeks, sorting cigarillo packages into flavor categories

4 weeks

Follow-up

Participants are monitored for changes in intentions and behaviors related to cigarillo smoking

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Package image sorting with FDA text-only warnings
• Package image sorting with pictorial warnings
• Package image sorting with Surgeon General text-only warnings

Trial Overview

The study tests how different warning formats on cigarillo packages affect users' intentions and behaviors. Over 6 weeks, participants sort ~20 packages by flavor while exposed to pictorial or text-only warnings, followed by a survey after 4 more weeks.

How Is the Trial Designed?

Group I: Pictorial warnings Experimental Treatment 1 Intervention

Participants randomized to this group will view pictorial cigarillo warnings.

Group II: FDA text-only warnings Active Control 1 Intervention

Participants randomized to this group will view FDA text-only warnings.

Group III: Surgeon General text-only warnings Active Control 1 Intervention

Participants randomized to this group will view Surgeon General text-only warnings.

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 3,371 adult smokers found that pictorial warning labels on tobacco packaging elicited significantly stronger reactions compared to text-only warnings, enhancing salience, perceived impact, and credibility, as well as increasing intentions to quit smoking.

The effectiveness of pictorial warnings was consistent across various racial/ethnic and socioeconomic groups, suggesting that these labels could help reduce communication inequalities and may be an effective tobacco control policy, especially for vulnerable communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tobacco-related health warning labels across socioeconomic, race and ethnic groups: results from a randomized web-based experiment. Cantrell, J., Vallone, DM., Thrasher, JF., et al.[2023]

A study involving 30 young adult cigarillo users found that graphic and 'gross' images are more effective at capturing attention and discouraging cigarillo use when paired with text warnings.

Participants preferred images that directly illustrated the warning text and included relatable figures, such as young adults making eye contact, which enhanced emotional engagement and perceived effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Pictorial Cigarillo Warnings: Insights From Focus Groups. Cornacchione Ross, J., King, JL., Lazard, AJ., et al.[2021]

Graphic warning labels on cigarette packages can evoke negative emotions that directly motivate adult smokers to intend to quit smoking, highlighting their potential effectiveness as a public health tool.

The study found that these labels also play an informational role by strengthening health risk beliefs among both adult smokers and non-smoking youth, suggesting that they can influence smoking behavior beyond just fear-based reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing competing explanations for graphic warning label effects among adult smokers and non-smoking youth. Skurka, C., Byrne, S., Davydova, J., et al.[2019]

Current users of cigars, including cigarillos and filtered cigars, are significantly more likely to notice warning labels compared to non-users, with noticing rates of 27% for cigarillos, 34% for filtered cigars, and 21% for traditional cigars.

The overall low rate of warning label noticing among the general population highlights the need for stronger and more uniform cigar warning label policies in the U.S., especially since awareness is higher among frequent users and those purchasing cigars in bulk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigar Warning Noticing and Demographic and Usage Correlates: Analysis from the United States Population Assessment of Tobacco and Health Study, Wave 5. Gratale, SK., Teotia, A., Chen-Sankey, J., et al.[2023]

Graphic warning labels significantly increased the perceived harm of moist snuff and e-cigarettes among 483 adult non-users of tobacco, suggesting that such labels can effectively communicate risks associated with these products.

Conversely, labels suggesting 'lower risk' or 'FDA Approved' decreased the perceived harm of moist snuff and snus, indicating that misleading endorsements can undermine public health efforts and should be regulated against.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsmokers' responses to new warning labels on smokeless tobacco and electronic cigarettes: an experimental study. Popova, L., Ling, PM.[2023]

Pictorial warnings on cigarillos were found to generate stronger negative emotional reactions and higher perceived message effectiveness compared to text-only warnings, particularly among recent users.

The study, which included 661 participants aged 18-29, indicates that pictorial warnings are more effective in promoting awareness of risks associated with cigarillo use, extending previous findings from cigarette warning research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responses to pictorial versus text-only cigarillo warnings among a nationally representative sample of US young adults. Cornacchione Ross, J., Lazard, AJ., King, JL., et al.[2023]

Pictorial warning labels (PWLs) on cigarette packs are associated with increased smoking cessation and reduced initiation, suggesting they could significantly impact public health.

The SimSmoke model predicts that implementing PWLs in the USA could reduce smoking prevalence by up to 10% in the long term and avert over 650,000 smoking-attributable deaths over the next 50 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health benefits from pictorial health warnings on US cigarette packs: a SimSmoke simulation. Levy, DT., Mays, D., Yuan, Z., et al.[2018]

A survey conducted in Rome with 227 adult participants found that plain packaging with pictorial warnings on cigarette packs is highly effective in reducing smoking initiation and motivating smokers to quit, with 90.9% believing it prevents initiation and 84.9% feeling motivated to quit.

The most impactful images were those depicting severe health consequences, such as gangrene and lung cancer, with 57.9% of smokers indicating they would change brands if faced with such warnings, highlighting the potential of graphic warnings to influence smoking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How would plain packaging and pictorial warning impact on smoking reduction, cessation and initiation?]. Mannocci, A., Colamesta, V., Mipatrini, D., et al.[2017]

Citations

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Accordingly, our findings suggest that pictorial cigar warnings could increase quit intentions, a hypothesis to be tested in future research.

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pmc.ncbi.nlm.nih.gov/articles/PMC5458743/

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Pictorial warnings on cigarette packs draw attention and increase quit intentions, but their effect on smoking behavior remains uncertain.

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Cigarette Labeling and Health Warning Requirements

WARNING: Smoking causes head and neck cancer. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Smoking causes cataracts, ...