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

928 Participants Needed

Trial Summary

What is the purpose of this trial?

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 using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

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 Little Cigar and Cigarillo Warnings for Youth?

Research shows that pictorial warnings (warnings with images) are more effective at discouraging cigarette use than text-only warnings. Although this has not been directly studied for cigarillos, the same principle may apply, suggesting that pictorial warnings could be more effective for discouraging cigarillo use among young people. ^{1 2 3 4 5}

How is the treatment 'Warning Labels for Youth Smoking' different from other treatments for youth smoking?

The treatment 'Warning Labels for Youth Smoking' is unique because it focuses on using warning labels as a preventive measure to reduce smoking among youth, rather than relying on traditional methods like nicotine replacement therapies or medications. This approach targets the psychological aspect of smoking by raising awareness and discouraging initiation through visual cues. ^{1 2 6 7 8}

Research Team

Leah Ranney, PhD, MA

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

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

User and Content Characteristics of Public Tweets Referencing Little Cigars. [2015]

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Flavors and Risk: Perceptions of Flavors in Little Cigars and Cigarillos Among U.S. Adults, 2015. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Themes in TikTok Videos Featuring Little Cigars and Cigarillos: Content Analysis. [2022]

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

Youth and Young Adult Blunt Use Predicts Progression to Other Nicotine Product Use in the United States. [2023]

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

'Sweeter Than a Swisher': amount and themes of little cigar and cigarillo content on Twitter. [2022]