Warnings for Tobacco Use

Overseen By Kristen Jarman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Under 21, Non-English speakers, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how different warnings on little cigar and cigarillo (LCC) packages affect attention and emotions. It examines the impact of removing flavor descriptions, such as "sweet," and using either picture or text-only warnings on people's reactions. Participants will view various mock LCC packages to measure their responses. The study seeks individuals who regularly use LCCs, can visit the study site in North Carolina, and have no eye conditions affecting eye tracking. As an unphased trial, it offers participants the opportunity to contribute to significant research on public health messaging.

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 method is safe for participants?

Research shows that testing warnings on little cigars and cigarillos (LCCs) is safe. These studies use non-invasive methods like eye tracking and surveys. Eye tracking follows eye movements, while surveys gather information about feelings. No drugs, needles, or risky procedures are involved.

Previous studies have not identified any safety issues with viewing warning labels. The research examines responses to various warning types, such as text-only or picture-based, and flavor descriptions like "sweet."

In summary, participating in a study examining these LCC packages poses no health risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these tobacco warning methods because they explore how different types of warnings on little cigar and cigarillo (LCC) packaging might influence consumer behavior. Unlike traditional tobacco warnings that often rely solely on text, this trial is testing the impact of pictorial warnings, which may be more attention-grabbing and memorable. Additionally, some packages include a "sweet" flavor descriptor to investigate how flavor labeling affects perceptions and choices. By comparing these different approaches, researchers hope to find out which warning style is most effective in reducing tobacco use and its appeal, potentially leading to more effective public health strategies.

What evidence suggests that this trial's treatments could be effective in influencing attention and affective responses to LCC warnings?

This trial will compare different warning labels on little cigars and cigarillos (LCCs). Participants will view mock LCC packages featuring either text-only or pictorial warnings, with or without a 'sweet' flavor descriptor. Studies have shown that graphic warnings on LCCs can increase the desire to quit smoking. Specifically, participants exposed to picture warnings reported a higher intention to quit, with an average score of 2.9. In contrast, the current text-only warnings from the FDA have not significantly changed smoking habits. Research suggests that the size and images in these warnings enhance their effectiveness. These findings indicate that strong images might help reduce smoking rates by encouraging people to quit. ^{1 3 5 6 7}

Who Is on the Research Team?

Adam O Goldstein

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who use tobacco products. Participants will be involved in a study that uses eye tracking and other measures to see how they react to different types of warnings on little cigar and cigarillo packages.

Inclusion Criteria

Pass quality/bot screening (will answer honestly, captcha, simple math question)

Current every day or some day users of LCC products

I am over 21 years old.

Exclusion Criteria

Unable to pass quality/bot screening

I am younger than 21 years old.

I cannot attend an in-person appointment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants' baseline attention, electrodermal activity, and affective responses are measured using eye tracking and galvanic skin response sensors.

1 week

1 visit (in-person)

Experimental Sessions

Participants view 12 LCC pack stimuli images with varying warning types and flavor descriptors. Attention and emotional responses are measured.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any changes in attention and affective responses post-experiment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Little Cigar and Cigarillo Warnings

Trial Overview The study is testing reactions to four combinations of package warnings: pictures with no flavor, text-only with 'sweet' flavor, text-only with no flavor, and pictures with 'sweet' flavor. The goal is to understand the impact on attention and feelings towards these warnings.

How Is the Trial Designed?

Group I: LCC Package with text-only warning and no flavor Experimental Treatment 1 Intervention

Participants will see a mock LCC package with text-only warnings and no flavor descriptor.

Group II: LCC Package with text-only warning and 'sweet' flavor Experimental Treatment 1 Intervention

Participants will see a mock LCC package with text-only warnings and a 'sweet' flavor descriptor

Group III: LCC Package with pictorial warning and no flavor Experimental Treatment 1 Intervention

Participants will see a mock LCC package with pictorial warnings and no flavor descriptor.

Group IV: LCC Package with pictorial warning and 'sweet' flavor Experimental Treatment 1 Intervention

Participants will see a mock LCC package with pictorial warnings and a 'sweet' flavor descriptor.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Food and Drug Administration (FDA)

Collaborator

Trials

184

Recruited

1,553,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Over 30% of cigarette smokers in the study reported using little cigars and cigarillos (LCCs) alongside cigarettes, with higher usage rates among Black/African American and Hispanic/Latino smokers compared to white smokers, indicating a significant prevalence of concomitant tobacco use.

The study highlights that sociodemographic factors, such as early onset of cigarette smoking and the use of other tobacco products, are associated with increased odds of LCC use, suggesting that targeted prevention programs are needed for at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Little Cigars and Cigarillos Use Among Young Adult Cigarette Smokers in the United States: Understanding Risk of Concomitant Use Subtypes. Sterling, KL., Fryer, CS., Pagano, I., et al.[2022]

A study analyzing over 4 million tweets about little cigars and cigarillos (LCCs) found that Twitter is a significant platform for marketing these products, especially among urban youth, with 17% of users being influencers who often promote LCC brands.

The research highlighted that 83% of tweets about LCCs referenced marijuana, indicating a normalization of co-use with cannabis, which raises concerns for public health and suggests a need for targeted prevention strategies that address LCC use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Sweeter Than a Swisher': amount and themes of little cigar and cigarillo content on Twitter. Kostygina, G., Tran, H., Shi, Y., et al.[2022]

A study of online vendors selling little cigars and cigarillos (LCCs) found that over 70% of these vendors offered flavored products, which are often perceived as less harmful than traditional cigarettes.

Many vendors employed ineffective age verification methods, with nearly half using proven inadequate strategies, highlighting the need for stricter regulations on age verification and flavored tobacco sales to protect youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet little cigar and cigarillo vendors: Surveillance of sales and marketing practices via website content analysis. Williams, RS., Derrick, JC.[2019]

Among young adults aged 18-34, 37.9% reported ever using cigars, with 46.2% being dual users of little cigars/cigarillos (LCCs) and large cigars (LCs), indicating a significant prevalence of cigar use in this demographic.

LCC-only users tend to be younger, predominantly female, and more likely to smoke cigarettes daily compared to LC-only users, suggesting that targeted interventions should address the specific characteristics and behaviors of different cigar user groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary and dual users of little cigars/cigarillos and large cigars: demographic and tobacco use profiles. Richardson, A., Rath, J., Ganz, O., et al.[2022]

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]

Over half of U.S. adults perceive flavors in flavored little cigars, cigarillos, and filtered cigars (LCCs) as risky, but a significant portion (over one-third) are unsure about the risks, indicating a gap in public knowledge.

Younger adults and LCC users are more likely to view these flavors as less risky, and those who perceive them as 'not at all risky' are about twice as likely to have used flavored LCCs, suggesting that risk perception is closely linked to actual use of these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavors and Risk: Perceptions of Flavors in Little Cigars and Cigarillos Among U.S. Adults, 2015. Nyman, AL., Sterling, KL., Majeed, BA., et al.[2023]

A study analyzing 811 TikTok posts related to little cigars and cigarillos (LCCs) found that the majority of content prominently featured LCCs, with themes like music, youth, and humor being common, indicating a strong presence of tobacco-related content among young users.

The findings suggest that TikTok may not be effectively enforcing its community guidelines against tobacco-related content, which could expose youth to harmful messages about LCC use, highlighting the need for better regulation and the creation of counteracting antitobacco content on the platform.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Themes in TikTok Videos Featuring Little Cigars and Cigarillos: Content Analysis. Vassey, J., Donaldson, SI., Dormanesh, A., et al.[2022]

A study analyzing 288 tweets about little cigars and cigarillos revealed that the majority of users were young males, indicating a demographic trend in LCC product engagement.

The content of the tweets often expressed product affiliation and smoking activity, suggesting that Twitter could be an effective platform for developing targeted public health interventions and counter-messaging strategies against tobacco use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User and Content Characteristics of Public Tweets Referencing Little Cigars. Step, MM., Bracken, CC., Trapl, ES., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11752031/

Impact of warning pictorials and size on perceived ... Accordingly, our findings suggest that pictorial cigar warnings could increase quit intentions, a hypothesis to be tested in future research.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/51/NCT05849051/Prot_SAP_ICF_000.pdf

Little Cigar and Cigarillo Warnings to Reduce Tobacco- ... FDA proposed text-only warnings. (Condition. 2). WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06546618/little-cigar-and-cigarillo-warnings-to-reduce-tobacco-related-cancers-and-disease-eye-tracking

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related ... Even smoking 1-2 cigars per day is associated with elevated cancer risk. Though cigarette consumption decreased 39% from 2000 to 2015, cigar consumption ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837632

Little Cigar and Cigarillo Graphic Health Warnings ... The fact that the FDA's current text-only warnings had no significant effect on behavioral intentions or outcomes is not surprising, ...

5. med.unc.edu med.unc.edu/fammed/2025/08/15/graphic-warnings-on-little-cigars-and-cigarillos-drive-higher-quit-rates-unc-study-shows/

Graphic Warnings on Little Cigars and Cigarillos Drive ... Increased Quit Intentions: Participants who saw graphic health warnings reported significantly higher intentions to quit (average score: 2.9 out ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357197/

Little Cigar and Cigarillo Graphic Health Warnings ... Although little cigars and cigarillos (LCCs) are common combustible tobacco products, the effects of LCC warning labels on behavioral outcomes remain untested.

7. wrdnews.org wrdnews.org/how-graphic-health-warnings-on-little-cigars-could-save-lives/

How Graphic Health Warnings on Little Cigars Could Save Lives Graphic health warnings on little cigars significantly increase quit rates and reduce tobacco use according to groundbreaking research.