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临床试验/NCT06477601
NCT06477601已完成不适用

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

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Cigarette changes from baseline to week 3

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

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.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current cigarette smoker
  • Smoke at least 5 cigarettes per day
  • Smoke on at least 25 of the past 30 days
  • Smoke menthol cigarettes for at least 1 year
  • At least 21 years old
  • Willing to try a product switch for 3 weeks and be followed for 6 weeks
  • Willing to not use marijuana in place of the study product
  • Willing to refrain from other tobacco product use for 3 weeks during the study
  • Speak and understand English
  • Willing to provide informed consent
  • Own cell or landline phone
  • Have reliable transportation
  • Plan to remain in the Kansas City area for the full duration of the study (6 weeks)
  • Bring pack of menthol cigarettes to W0 study visit

排除标准

  • E-cigarette use on greater than 4 of the past 30 days
  • Other tobacco product use on greater than 4 of the past 30 days
  • Interested in quitting smoking (i.e., setting a quit date) in the next 30 day
  • Current use of cessation medications
  • Household member currently or previously enrolled in the study
  • Currently pregnant
  • Unable to provide informed consent

结局指标

主要结局

Cigarette changes from baseline to week 3

时间窗: 3 weeks

4.1 The primary study endpoint is changes in total cigarettes per day from baseline to week 3.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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