Little Cigar and Cigarillo Warnings for Youth

Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use

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.

Study Overview

• Status: Completed
• Conditions: Little Cigars and Cigarillos (LCC) Use
• Intervention / Treatment: Behavioral: FDA warnings + Image; Behavioral: FDA Warnings Text-Only; Behavioral: Surgeon General Text-Only Warnings

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 928
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Lineberger Comprehensive Cancer Center at University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
2. Agree to provide their honest answers
3. 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
4. Age 15 - 20 years old
5. Currently living in US or US territory
6. Able to complete 2 surveys that take approximately 15 minutes
7. Able to complete a 2-minute survey each day for 6 days
8. Able to verify they are not a bot using CAPTCHA
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FDA warnings + Image; Participants will receive FDA-proposed LCC warnings with images	Behavioral: FDA warnings + Image; 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.
Experimental: FDA Warnings Text-Only Warnings; Participants will receive FDA-proposed text-only LCC warnings.	Behavioral: FDA Warnings Text-Only; Participants will receive messages including images in 30% size.
Active Comparator: Surgeon General Text-Only Warnings; Participants will receive Surgeon General text-only LCC warnings.	Behavioral: Surgeon General Text-Only Warnings; Participants will receive messages including Surgeon General Text-only Warnings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Willingness to Use Little Cigars Cigarillos (LCCs)	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.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Past 7 Days Little Cigar Use	The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item.	Day 8
Past 7 Days Cigarillo Use	The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item.	Day 8
Little Cigar and Cigarillos (LCCs) Susceptibility	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.	Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 2
Warning Negative Affect/Worry	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.	Day 2
Knowledge of Little Cigar and Cigarillo (LCC) Harms	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.	Day 8
Beliefs About Little Cigar and Cigarillo (LCC) Harms	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.	Day 8
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 3
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 4
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 5
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 6
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 7
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use	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.	Day 8
Warning Negative Affect/Worry	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.	Day 3
Warning Negative Affect/Worry	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.	Day 4
Warning Negative Affect/Worry	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.	Day 5
Warning Negative Affect/Worry	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.	Day 6
Warning Negative Affect/Worry	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.	Day 7

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); Food and Drug Administration (FDA)
• Investigators: Principal Investigator: Leah Ranney, PhD, MA, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Clinical trials at UNC Lineberger

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Actual): November 25, 2024
• Study Completion (Actual): November 25, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: youth; cancer prevention; nicotine addiction; cigarette warnings; smoke cigars; Black or African American youth
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 23-2455; 5R01CA260822-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No