Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477601
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-21
Brief Title:
Cooling Agent Pilot Among Adult Menthol Smokers
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Impact of WS-3 Menthol and Non-menthol Cigarettes on Cigarette Smoking and Abuse Liability Among Adult Menthol Smokers A Pilot Investigation
Status:
ACTIVE_NOT_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:
Recent studies and market monitoring have shown that in places where menthol cigarettes are no longer available tobacco companies have started marketing non-menthol cooling cigarettes Little is known about what current menthol smokers think of these non-menthol cooling cigarettes and how they compare to regular menthol cigarettes By doing this study the investigators hope to learn what menthol smokers think of these cigarettes and how they impact how menthol smokers smoke
Detailed Description:
The Food and Drug Administration has been considering a potential federal restriction on menthol as a characterizing flavor in combustible cigarettes a policy that would likely significantly reduce tobacco related disparities among Black adults who smoke menthol cigarette However in states where this policy has been enacted and menthol cigarettes are off the market the tobacco industry has circumvented the restriction by introducing new non-menthol cigarettes that include WS-3 a chemical that acts as a cooling agent but without use of menthol Our team is interested in understanding the extent to which WS-3 undermines a potential future menthol ban and the impact on the reduction in cigarettes smoked particularly among Black adults who smoke
The overall objective of this application is to obtain effect sizes and establish feasibility for an upcoming R01 submission Specific aims include Aim1 Determine the change in total cigarettes per day CPD when using menthol cigarettes WS-3 cigarettes and traditional non-menthol cigarettes The primary comparison is between WS-3 and traditional non-menthol cigarettes Aim 2 Understand the comparative abuse liability during ad libitum use of menthol cigarettes WS-3 synthetic cooling agent cigarettes and traditional non-menthol cigarettes The study intervention involves providing study participants who are all adult current smokers with no intention to quit or alter their cigarette smoking with either menthol cigarettes WS-3 synthetic cooling agent cigarettes or traditional non-menthol cigarettes All study products are commercially available Participants will report on their usual number of cigarettes per day and will be provided a commensurate amount of study cigarettes to allow them to make a complete switch to the study product for the duration of the 6 week research study
The overall objective of this application is to obtain effect sizes and establish feasibility for an upcoming R01 submission Specific aims include Aim1 Determine the change in total cigarettes per day CPD when using menthol cigarettes WS-3 cigarettes and traditional non-menthol cigarettes The primary comparison is between WS-3 and traditional non-menthol cigarettes Aim 2 Understand the comparative abuse liability during ad libitum use of menthol cigarettes WS-3 synthetic cooling agent cigarettes and traditional non-menthol cigarettes The study intervention involves providing study participants who are all adult current smokers with no intention to quit or alter their cigarette smoking with either menthol cigarettes WS-3 synthetic cooling agent cigarettes or traditional non-menthol cigarettes All study products are commercially available Participants will report on their usual number of cigarettes per day and will be provided a commensurate amount of study cigarettes to allow them to make a complete switch to the study product for the duration of the 6 week research study
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