Little Cigar and Cigarillo Warnings for Youth

NCT ID: NCT06413797

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 928 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-18
• Study Completion Date: 2024-11-25

Brief Summary

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.

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.

Conditions

Little Cigars and Cigarillos (LCC) Use

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

FDA warnings + Image

Participants will receive FDA-proposed LCC warnings with images

Group Type: EXPERIMENTAL

FDA warnings + Image

Intervention Type: 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 Warnings

Participants will receive FDA-proposed text-only LCC warnings.

Group Type: EXPERIMENTAL

FDA Warnings Text-Only

Intervention Type: BEHAVIORAL

Participants will receive messages including images in 30% size.

Surgeon General Text-Only Warnings

Participants will receive Surgeon General text-only LCC warnings.

Group Type: ACTIVE_COMPARATOR

Surgeon General Text-Only Warnings

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

FDA Warnings Text-Only

Participants will receive messages including images in 30% size.

Intervention Type: BEHAVIORAL

Surgeon General Text-Only Warnings

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leah Ranney, PhD, MA

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

Clinical trials at UNC Lineberger

Other Identifiers

5R01CA260822-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2455

Identifier Type: -

Identifier Source: org_study_id