Clinical trial NCT06413797: Little Cigar and Cigarillo Warnings for Youth
Official title: Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Little Cigars and Cigarillos (LCC) Use
Keywords: cigarette warnings
youth
smoke cigars
nicotine addiction
cancer prevention
Black or African American youth
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Food and Drug Administration (FDA)
First posted: 2024-05-14
Enrollment: 928
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Willingness to use little cigars cigarillos (LCCs)
timeFrame: Day 8
Secondary outcomes:
measure: Past 7 days little cigar use
timeFrame: Day 8
measure: Past 7 days cigarillo use
timeFrame: Day 8
measure: Little cigar and cigarillos (LCCs) susceptibility
timeFrame: Day 8
measure: Cognitive elaboration about risk of little cigar and cigarillo use
timeFrame: Days 2,3,4,5,6,7,8
measure: Warning negative affect/worry
timeFrame: Days 2,3,4,5,6,7,8
measure: Knowledge of little cigar and cigarillo (LCC) harms
timeFrame: Day 8
measure: Beliefs about little cigar and cigarillo (LCC) harms
timeFrame: Day 8
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Leah Ranney, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References: