928 Participants Needed

Warning Labels for Youth Smoking

KJ
Overseen ByKristen Jarman
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.12678

Research Team

LR

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
See 1 more

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
3Treatment groups
Experimental Treatment
Active Control
Group I: FDA warnings + ImageExperimental Treatment1 Intervention
Participants will receive FDA-proposed LCC warnings with images
Group II: FDA Warnings Text-Only WarningsExperimental Treatment1 Intervention
Participants will receive FDA-proposed text-only LCC warnings.
Group III: Surgeon General Text-Only WarningsActive Control1 Intervention
Participants will receive Surgeon General text-only LCC warnings.

Find a Clinic Near You

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

References

Internet little cigar and cigarillo vendors: Surveillance of sales and marketing practices via website content analysis. [2019]
User and Content Characteristics of Public Tweets Referencing Little Cigars. [2015]
Developing Pictorial Cigarillo Warnings: Insights From Focus Groups. [2021]
Responses to pictorial versus text-only cigarillo warnings among a nationally representative sample of US young adults. [2023]
Flavors and Risk: Perceptions of Flavors in Little Cigars and Cigarillos Among U.S. Adults, 2015. [2023]
Themes in TikTok Videos Featuring Little Cigars and Cigarillos: Content Analysis. [2022]
Youth and Young Adult Blunt Use Predicts Progression to Other Nicotine Product Use in the United States. [2023]
'Sweeter Than a Swisher': amount and themes of little cigar and cigarillo content on Twitter. [2022]
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