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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continued menthol smoking | Active Comparator | Current menthol smokers will be assigned to smoke study provided menthol cigarettes. |
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| Synthetic cooling agent cigarette smoking | Experimental | Current menthol smokers will be assigned to smoke study provided synthetic cooling agent cigarettes. |
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| Traditional non-menthol cigarette smoking | Experimental | Current menthol smokers will be assigned to smoke study provided traditional non-menthol cigarettes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assigning cooling agent type cigarettes | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette changes from baseline to week 3 | 4.1 The primary study endpoint is changes in total cigarettes per day from baseline to week 3. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleanor Leavens, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Tobacco Treatment Center | Kansas City | Missouri | 64130 | United States |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Participants will be 20 adult current menthol smokers. Participants will be randomized to continued menthol smoking (n = 4), WS-3 synthetic cooling agent cigarette smoking (n = 8), or traditional non-menthol cigarette smoking (n = 8).
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Participants and investigators will be blind during randomization. Participants will be randomly assigned to their arm, but once assigned, participants and investigators will know which product they have been assigned to.
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| Assigning traditional tobacco type cigarettes | Other | 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. |
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| Assigning menthol type cigarettes | Other | This comparison group is for where the Food and Drug Administration does not ban menthol cigarettes. |
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