NCT06477601

Cooling Agent Pilot Among Adult Menthol Smokers

Impact of WS-3, Menthol, and Non-menthol Cigarettes on Cigarette Smoking and Abuse Liability Among Adult Menthol Smokers: A Pilot Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
OTHER	Assigning cooling agent type cigarettes	This study is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol cigarettes but allows cooling agent cigarettes.
OTHER	Assigning traditional tobacco type cigarettes	This comparison group is intended to help understand what people who smoke menthol cigarettes would do in a scenario where the Food and Drug Administration bans menthol and cooling agent cigarettes.
OTHER	Assigning menthol type cigarettes	This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes.

Timeline

• Start date: 2024-06-24
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2024-06-27
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States