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, especially Black/African American youth. 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: Not yet recruiting
• Conditions: Little Cigars and Cigarillos (LCC) Using
• Intervention / Treatment: Behavioral: Survey; Behavioral: FDA-proposed Text messages; Behavioral: Images; Behavioral: Surgeon General Text messages

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 (Estimated): 2100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Jarman; Phone Number: 919-445-4208; Email: jkristen@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Lineberger Comprehensive Cancer Center at University of North Carolina
      • Contact: Kristen Jarman; Phone Number: 919-445-4208; Email: jkristen@email.unc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.
• Age 15 - 20 years old
• Currently living in US or US territory

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: Text Image; Subjects will receive messages including FDA-proposed LCC warnings and Images in 30% size. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.	Behavioral: Survey; For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey.; Behavioral: FDA-proposed Text messages; Participants will receive messages including FDA-proposed LCC warnings.; Behavioral: Images; Participants will receive messages including images in 30% size.
Experimental: Text-only; Subjects will receive text messages including FDA-proposed LCC warnings. Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.	Behavioral: Survey; For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey.; Behavioral: FDA-proposed Text messages; Participants will receive messages including FDA-proposed LCC warnings.
Active Comparator: Control; Participants will be contacted each day to invite them to complete the survey for that day of the study protocol.	Behavioral: Survey; For six subsequent days (days 2-7) participants will be contacted and asked to complete a daily survey.; Behavioral: Surgeon General Text messages; 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 cigar 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	Past 7 days little cigar use will be measured with separate items for cigarillo and little cigar use by the survey.	Day 8
Past 7 days cigarillos use	Past 7 days cigarillos use will be measured with separate items for cigarillo and little cigar use by survey.	Day 8
little cigar cigarillos (LCCs) susceptibility	little cigar cigarillo (LCC) susceptibility will be measured with 3 items by survey.	Day 8
Cognitive elaboration about dangers	Cognitive elaboration about dangers will be measured by the survey.	Days 1,2,3,4,5,6,7,8
Cognitive elaboration about risk	Cognitive elaboration about dangers will be measured by the survey.	Day 8
Cigar appeal	Cigar appeal will be measured by the survey.	Days 1,2,3,4,5,6,7,8
Warning relevance	Warning relevance will be measured by the survey.	Days 1,2,3,4,5,6,7,8
Warning negative affect/worry	Warning negative affect/worry will be measured by the survey.	Days 1,2,3,4,5,6,7,8
Past 7 day little cigar cigarillos (LCCs) use	Past 7 day little cigar cigarillos (LCCs) use will be measured by the survey.	Day 8
Knowledge of little cigar cigarillo (LCC) harms	Knowledge of LCC harms will be measured by 13 items the survey.	Day 8
Beliefs about little cigar cigarillo (LCC) harms	Beliefs about little cigar cigarillo (LCC) harms will be measured with 10 items by survey.	Day 8
Little cigar cigarillo (LCC) risk perceptions	LCC risk perceptions	Day 8
Reactance to warnings	Reactance to warnings will be measured by survey.	Day 8
Conversations about cigar health risks	Conversations about cigar health risks will be measured by survey.	Day 8

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 (Estimated): June 1, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

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): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: youth; cancer prevention; nicotine addiction; cigarette warnings; smoke cigars; Black or African American youth
• 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