Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413797
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-09
Brief Title:
Little Cigar and Cigarillo Warnings for Youth
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 76 which translates into 11 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 2courts 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 BlackAfrican Americans and use LCCs on fewer days per month
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 2courts 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 BlackAfrican Americans and use LCCs on fewer days per month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01CA260822-03 | NIH | None | httpsreporternihgovquickSearch5R01CA260822-03 |