Warning Labels for Youth Smoking

Overseen By Kristen Jarman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Bot, Math question, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how warning labels on little cigars and cigarillos (LCCs) affect young people's smoking habits. Researchers aim to determine if warnings with images or text can reduce LCC use among youth. Participants will receive various types of warnings, some featuring images and others with only text. Ideal participants are young people in the U.S. who are curious about LCCs, have used them before, or currently use them. As an unphased trial, this study provides a unique opportunity for young people to contribute to research that could influence public health policies.

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 these warning labels are safe for youth?

Research has shown that warning labels on little cigars and cigarillos (LCCs) are safe. One study found that graphic health warnings, which include pictures, can help people quit smoking by increasing awareness of the risks. These warnings have not caused any harm.

Similarly, the FDA's text-only warnings, which lack pictures, are also safe. However, studies suggest these text-only warnings are less effective at encouraging smoking cessation compared to graphic warnings.

Overall, both types of warnings are safe. They aim to inform and potentially reduce smoking among young people without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different types of warning labels on little cigars and cigarillos might impact youth smoking. While traditional warnings often rely on text from the Surgeon General, this trial includes new, visually impactful FDA-proposed warnings that combine images with text. The aim is to see if these warnings can better capture the attention of young people and effectively communicate the risks of smoking. By comparing image-based and text-only warnings, researchers hope to identify the most effective approach to reduce youth smoking rates.

What evidence suggests that this trial's treatments could be effective for reducing youth LCC use?

Research shows that picture warnings on little cigars and cigarillos (LCCs) can help reduce their use among young people. Studies have found that these images increase the likelihood of quitting and reducing tobacco use. The pictures capture attention and make the health risks more memorable. In this trial, participants will receive either FDA-proposed LCC warnings with images or text-only warnings. The FDA's text-only warnings have not effectively changed behavior or encouraged quitting. Graphic warnings seem to be a stronger method to discourage youth from using LCCs. ^{1 2 4 6 7}

Who Is on the Research Team?

Leah Ranney, PhD, MA

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for young people who currently use, have used before, or might use little cigars and cigarillos (LCCs), with a focus on Black/African American youth. The study aims to understand how warnings affect their views and choices about LCCs.

Inclusion Criteria

I am between 15 and 20 years old.

Agree to provide their honest answers to the survey questionnaire

Susceptible to using little cigars and cigarillos (LCC) or have ever used little cigars and/or cigarillos, or currently use little cigars and/or cigarillos in the past 30 days

Exclusion Criteria

Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA)

I cannot solve a simple math question when asked.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive different types of LCC warnings, including FDA-proposed warnings with images, text-only warnings, and Surgeon General text-only warnings

8 days

Daily surveys

Follow-up

Participants are monitored for changes in willingness to use LCCs and beliefs about LCC harms

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Little Cigar and Cigarillo Warnings for Youth

Trial Overview The study tests the impact of different types of warnings on youth attitudes towards LCCs. These include FDA-proposed text messages, images, and Surgeon General Text messages delivered through surveys.

How Is the Trial Designed?

Group I: FDA warnings + Image Experimental Treatment 1 Intervention

Participants will receive FDA-proposed LCC warnings with images

Group II: FDA Warnings Text-Only Warnings Experimental Treatment 1 Intervention

Participants will receive FDA-proposed text-only LCC warnings.

Group III: Surgeon General Text-Only Warnings Active Control 1 Intervention

Participants will receive Surgeon General text-only LCC warnings.

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

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]

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]

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]

Young adults who smoke blunts (modified cigars used for cannabis) are significantly more likely to start using other tobacco products, such as cigars, e-cigarettes, and cigarettes, compared to those who do not smoke blunts, based on a study of 5,284 nicotine-naïve participants over four years.

The study indicates that blunt use is a key factor in initiating nicotine use, highlighting a potential risk pathway for young users, while cannabis use alone does not show the same association with starting tobacco products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth and Young Adult Blunt Use Predicts Progression to Other Nicotine Product Use in the United States. Kreslake, JM., Mills, S., Liu, M., 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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06413797

NCT06413797 | Little Cigar and Cigarillo Warnings for Youth In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC ...

2. 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11847773/

An Experimental Study Among a Sample of US Young Adults This study assessed the relative efficacy of six FDA-proposed individual warning statements in text and pictorial format. A sample of young ...

4. 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 ... Key results include: Increased Quit Intentions: Participants who saw graphic health warnings reported significantly higher intentions to quit ( ...

5. careacross.com careacross.com/clinical-trials/trial/NCT06413797

Little Cigar and Cigarillo Warnings for Youth Summary: This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to ...

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

Little Cigar and Cigarillo Graphic Health Warnings ... However, the current US Food and Drug Administration (FDA) text-only warnings on cigars, including LCCs, appear insufficient in influencing short-term user ...

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 The study found that existing FDA text-only warnings had no real effect on people's intentions or behaviours. Even though most participants had ...