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Completed

NCT Number: NCT06413797

Little Cigar and Cigarillo Warnings for Youth

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.

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Key information

Conditions

Little Cigars and Cigarillos (LCC) Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, 27514, United States

About this study

Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other 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 packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.

Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
  • Agree to provide their honest answers
  • Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
  • Age 15 - 20 years old
  • Currently living in US or US territory
  • Able to complete 2 surveys that take approximately 15 minutes
  • Able to complete a 2-minute survey each day for 6 days
  • Able to verify they are not a bot using CAPTCHA
  • Able to answer a simple, random math question

Exclusion criteria

  • Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
  • Not able to answer a simple, random math question.

Treatment and study plan

FDA warnings + Image

Behavioral

For six days (days 2-7) participants will be contacted and asked to complete a daily survey. As part of the survey, participants will view FDA-proposed LCC warnings with images at 30% size on a cigarillo package. Participants will be contacted each day to be invited to complete the survey for that day of the study protocol.

FDA Warnings Text-Only

Behavioral

Participants will receive messages including images in 30% size.

Surgeon General Text-Only Warnings

Behavioral

Participants will receive messages including Surgeon General Text-only Warnings.

Primary outcomes

  1. Willingness to Use Little Cigars Cigarillos (LCCs)

    Time frame: Day 8

    The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.

Secondary outcomes

  1. Past 7 Days Little Cigar Use

    Time frame: Day 8

    The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item.

  2. Past 7 Days Cigarillo Use

    Time frame: Day 8

    The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item.

  3. Little Cigar and Cigarillos (LCCs) Susceptibility

    Time frame: Day 8

    The average susceptibility to little cigar and cigarillo (LCC) use measured with the average of 3 survey item scores. Question scoring is on a scale of 1 to 4, where 1 indicates high susceptibility and 4 indicates low susceptibility to LCCs.

  4. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 2

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  5. Warning Negative Affect/Worry

    Time frame: Day 2

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

  6. Knowledge of Little Cigar and Cigarillo (LCC) Harms

    Time frame: Day 8

    Knowledge of LCC harms will be measured by 12 items the survey. Scores can range from 0 to 12 and indicate the number of questions out of 12 about LCC harms that participants answered correctly.

  7. Beliefs About Little Cigar and Cigarillo (LCC) Harms

    Time frame: Day 8

    The average score on beliefs about LCC harms measured with 10 items by survey, are an average of the responses to the 10 questions. Belief scoring is on a scale of 1 to 5, where 1 indicates strong disagreement with statements about the health harms of LCCs and 5 indicates strong agreement with the statements about the health harms of LCCs.

  8. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 3

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  9. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 4

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  10. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 5

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  11. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 6

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  12. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 7

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  13. Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use

    Time frame: Day 8

    The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.

  14. Warning Negative Affect/Worry

    Time frame: Day 3

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

  15. Warning Negative Affect/Worry

    Time frame: Day 4

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

  16. Warning Negative Affect/Worry

    Time frame: Day 5

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

  17. Warning Negative Affect/Worry

    Time frame: Day 6

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

  18. Warning Negative Affect/Worry

    Time frame: Day 7

    Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI)

Registry information

Official study title

Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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