Grant Number:	5R01CA260822-03 Interpret this number
Primary Investigator:	Ranney, Leah
Organization:	Univ Of North Carolina Chapel Hill
Project Title:	Strengthening Cigar Warnings to Prevent Adolescent Use
Fiscal Year:	2023

ABSTRACT Over 1.4 million youth currently smoke cigars and recent data from the National Youth Tobacco Survey (2019) indicate that cigars are the second most commonly used tobacco product among youth. Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases their risks for multiple cancers and premature death. 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/African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) mandated six rotating text-only warning statements to be on LCC packaging. Little research has examined the effectiveness of the FDA-mandated LCC warnings in reducing youth willingness to use LCCs. Research from studies of cigarettes suggests that effective warnings should be large and include images that illustrate the negative health effects associated with use. However, evidence for cigarette warnings cannot adequately inform implementation of improved LCC warnings because: 1) there is no evidence on the effectiveness of the FDA- mandated text-only LCC warnings on behavioral intentions or outcomes among youth; 2) courts have ruled that effective tobacco warnings on one type of tobacco product (i.e., cigarettes) cannot be used to justify warnings on other types of tobacco (i.e., LCCs), and 3) LCC users have different demographic and consumption profiles than cigarette users. Furthermore, the US Court of Appeals for the DC Circuit recently ruled that the FDA cannot require warning labels for cigars, claiming that the FDA did not provide evidence on the impact of cigar warnings on smoking rates, including initiation and cessation. Our goal is to conduct research that advances the science on LCC warnings that are effective for youth ages 15 – 20 who currently use, have ever used, or are susceptible to using LCCs, especially Black/African American youth. We will achieve three aims over the three-year grant. Aim 1 will identify the most effective images to pair with FDA-mandated LCC text-only warning statements using a youth advisory board and a quantitative online survey delivered to 500 youth. Aim 2 will experimentally examine whether LCC warning size (30% vs 50%) and type (text-only vs. text + image) affect perceived message effectiveness of LCC warnings among a separate online sample of 500 youth. In Aim 3, we will conduct a randomized controlled trial with 900 youth to test whether the most effective LCC warnings from Aim 2 reduce willingness to use LCCs against the text-only 30% size FDA-mandated LCC warnings and a control condition. Our Aim 3 trial will be delivered to youth through an online survey link embedded in text messages. Our study will provide data and actionable evidence that FDA and policy makers need to implement strengthened LCC warnings aimed to reduce LCC use among youth and decrease tobacco-related disparities.





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