Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546618
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research is to determine how removal of little cigar and cigarillo LCC flavor descriptors on packaging impacts attention and affective responses to LCC warnings A study will be conducted using eye tracking electrodermal activity galvanic skin response and survey measures of affect to measure participant responses to LCC packages varied by warning type pictorial vs text only and flavor contents Sweet flavor descriptor vs no flavor descriptor
Detailed Description:
Over 4 million US adults regularly smoke cigars which causes multiple cancers including oral esophageal pancreatic laryngeal and lung cancer Even smoking 1-2 cigars per day is associated with elevated cancer risk Though cigarette consumption decreased 39 from 2000 to 2015 cigar consumption increased 85 Of the three major types of cigars-large cigars little cigars and cigarillos-little cigars and cigarillos LCC are the most commonly used in the US LCC use among adults has increased in part because LCCs are taxed at a lower rate than cigarettes are subject to fewer regulations and marketing restrictions can be purchased in small pack sizes and are exempt from flavor bans that apply to cigarettes
In May 2016 the Food and Drug Administration FDA required text-only warnings on LCC packs rotating among six statements Research on cigarettes suggests warnings on packs should have multiple rotating sets contain images illustrating the negative health effects associated with LCC use and be large However the evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for four reasons 1 The currently mandated cigar warnings differ from existing cigarette warnings 2 there is no evidence on the effectiveness of the currently mandated cigar warnings ie behavioral intentions or outcomes or evidence on efforts that might improve LCC warnings ie images larger warning size removal of LCC flavor descriptors on packaging 3 Courts have ruled that one type of effective tobacco warning ie for cigarettes cannot be used to justify other types of tobacco warnings such as those for LCCs and 4 LCC users have different demographic and consumption profiles than cigarette users ie LCC users include a higher proportion of young adults African Americans and LCCs are used on fewer days per month which should be taken into account when developing improved warnings
Gaps exist in understanding how LCC policies such as the removal of flavor descriptors on packaging influence the impact of LCC warnings This eye tracking and psychophysiology project will provide new data to fill these evidence gaps and advance general scientific knowledge about elements of tobacco warnings research
During the study Participants will see 12 LCC pack stimuli images presented in random order 3 packs will feature pictorial LCC warnings and a Sweet flavor descriptor and the same 3 warnings will be presented on packs without a flavor The remaining 6 LCC packs will have 3 text-only warnings with 3 images containing the Sweet flavor and 3 images without a flavor We will measure attention to the warnings and attention to the flavor descriptors as well as electrodermal activity and affective responses for each of the 12 stimuli
In May 2016 the Food and Drug Administration FDA required text-only warnings on LCC packs rotating among six statements Research on cigarettes suggests warnings on packs should have multiple rotating sets contain images illustrating the negative health effects associated with LCC use and be large However the evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for four reasons 1 The currently mandated cigar warnings differ from existing cigarette warnings 2 there is no evidence on the effectiveness of the currently mandated cigar warnings ie behavioral intentions or outcomes or evidence on efforts that might improve LCC warnings ie images larger warning size removal of LCC flavor descriptors on packaging 3 Courts have ruled that one type of effective tobacco warning ie for cigarettes cannot be used to justify other types of tobacco warnings such as those for LCCs and 4 LCC users have different demographic and consumption profiles than cigarette users ie LCC users include a higher proportion of young adults African Americans and LCCs are used on fewer days per month which should be taken into account when developing improved warnings
Gaps exist in understanding how LCC policies such as the removal of flavor descriptors on packaging influence the impact of LCC warnings This eye tracking and psychophysiology project will provide new data to fill these evidence gaps and advance general scientific knowledge about elements of tobacco warnings research
During the study Participants will see 12 LCC pack stimuli images presented in random order 3 packs will feature pictorial LCC warnings and a Sweet flavor descriptor and the same 3 warnings will be presented on packs without a flavor The remaining 6 LCC packs will have 3 text-only warnings with 3 images containing the Sweet flavor and 3 images without a flavor We will measure attention to the warnings and attention to the flavor descriptors as well as electrodermal activity and affective responses for each of the 12 stimuli
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None