Little Cigar and Cigarillo Warnings for Youth

Trial Title: Little Cigar and Cigarillo Warnings for Youth

NCT ID: NCT06413797

Condition: Little Cigars and Cigarillos (LCC) Use

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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: FDA warnings + Image
Description: 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.
Arm group label: FDA warnings + Image

Intervention type: Behavioral
Intervention name: FDA Warnings Text-Only
Description: Participants will receive messages including images in 30% size.
Arm group label: FDA Warnings Text-Only Warnings

Intervention type: Behavioral
Intervention name: Surgeon General Text-Only Warnings
Description: Participants will receive messages including Surgeon General Text-only Warnings.
Arm group label: Surgeon General Text-Only Warnings

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.

Criteria for 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.

Gender: All

Minimum age: 15 Years

Maximum age: 20 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Lineberger Comprehensive Cancer Center at University of North Carolina

Address:
City: Chapel Hill
Zip: 27514
Country: United States

Status: Recruiting

Contact:
Last name: Kristen Jarman

Phone: 919-966-3016
Email: jkristen@email.unc.edu

Start date: July 18, 2024

Completion date: February 8, 2026

Lead sponsor:
Agency: UNC Lineberger Comprehensive Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: Food and Drug Administration (FDA)
Agency class: U.S. Fed

Source: UNC Lineberger Comprehensive Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06413797
http://unclineberger.org/patientcare/clinical-trials/clinical-trials