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

764 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment involving warning labels on cigarillo packages?

Research shows that pictorial warnings are more effective than text-only warnings in discouraging smoking and informing smokers about health risks. Studies have found that pictorial warnings on cigarette packages are more impactful in motivating people to quit smoking and change their smoking habits compared to text-only warnings. ^{1 2 3 4 5}

Is it safe for humans to participate in clinical trials about warning labels on cigarillo packages?

The research does not provide specific safety data for humans participating in trials about warning labels on cigarillo packages, as it focuses on the effectiveness of different types of warnings rather than safety concerns. ^{1 2 3 4 6}

How do warning labels on cigarillo packages differ from other treatments for smoking?

This treatment uses pictorial warnings on cigarillo packages, which are more effective at discouraging use compared to text-only warnings. Unlike traditional smoking cessation methods, this approach focuses on visual impact to influence behavior. ^{2 3 6 7 8}

What is the purpose of this trial?

The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format. For 4 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of \~18 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert). At the end of the study, participants will be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation. The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.

Research Team

Jennifer Ross, PhD

Principal Investigator

School of Public Health - Health Law Policy & Management Dept

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Developing Pictorial Cigarillo Warnings: Insights From Focus Groups. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Responses to pictorial versus text-only cigarillo warnings among a nationally representative sample of US young adults. [2023]

4. Switzerland 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. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

[How would plain packaging and pictorial warning impact on smoking reduction, cessation and initiation?]. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Public health benefits from pictorial health warnings on US cigarette packs: a SimSmoke simulation. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Testing competing explanations for graphic warning label effects among adult smokers and non-smoking youth. [2019]

8. England pubmed.ncbi.nlm.nih.gov

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