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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. A study will be conducted using eye tracking, electrodermal activity (galvanic skin response), and survey measures of affect to measure participant responses to LCC packages varied by warning type (pictorial vs. text only) and flavor contents ('Sweet' flavor descriptor vs. no flavor descriptor).

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?

Research shows that pictorial warnings are more effective than text-only warnings for cigarettes, suggesting that similar pictorial warnings for cigarillos could also be more effective in communicating health risks. ^{1 2 3 4 5}

Is there safety data available for Little Cigars and Cigarillos (LCCs)?

The research highlights that Little Cigars and Cigarillos (LCCs) are popular and pose unique health risks, especially due to their flavors. They are perceived as less harmful than cigarettes, but they are minimally regulated and widely available, which can increase health risks, particularly among young people. ^{1 3 5 6 7}

How does the treatment for tobacco use differ from other treatments?

The treatment for tobacco use in this trial is unique because it focuses on providing warnings specifically for little cigars and cigarillos (LCCs), which are often perceived as less harmful than cigarettes and are minimally regulated. This approach is different from other treatments that may not address the specific risks and marketing practices associated with LCCs. ^{2 3 5 7 8}

Research Team

Adam O Goldstein

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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. England pubmed.ncbi.nlm.nih.gov

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

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

Primary and dual users of little cigars/cigarillos and large cigars: demographic and tobacco use profiles. [2022]

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

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

4. England 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. [2022]

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

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

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

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

7. Canada pubmed.ncbi.nlm.nih.gov

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

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

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