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临床试验/NCT04879225
NCT04879225已完成不适用

The Impact of Menthol and Mint E-liquid Bans on Menthol Cigarette Smokers

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年6月21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
66
试验地点
2
主要终点
Total Amount of Combusted Tobacco Purchased

研究概览

简要总结

Menthol cigarettes comprise almost one-third of the United States (US) market share and are disproportionately smoked by racial minorities. Tobacco control policies targeting menthol flavoring in tobacco could have significant public health outcomes, especially among black smokers. One key challenge of tobacco regulation is weighing the risks and benefits of potential policies across different populations (i.e., users and non-users). Tension arises between policies intended to prevent adolescent and young adult (AYA) tobacco initiation and those intended to reduce harm among current tobacco users. The availability of menthol e-liquids may be important for encouraging menthol cigarette smokers to switch to e- cigarettes, but mint e-liquids, which are appealing to AYA, may be unnecessary to facilitate switching. Including mint e-liquids in flavor bans but allowing menthol e-liquids to remain on the market as potential substitution products for menthol smokers may be an optimal policy approach. The study team is proposing a lab study and field assessment to determine how including menthol and mint e-liquids in e-liquid flavor bans or sales restrictions affects tobacco product purchasing and use among menthol cigarette smokers. At lab sessions, participants will complete the Experimental Tobacco Marketplace (ETM) task, a behavioral economics task in which they receive account balances to an online store and can buy menthol cigarettes at escalating costs or buy e-liquids, non-menthol cigarettes, or nicotine replacement gum at fixed costs. They will complete the task under four marketplace conditions: (1) only tobacco e-liquids available, (2) menthol and tobacco e-liquids available, (3) menthol, mint, and tobacco e-liquids available, and (4) tobacco, menthol, mint, fruit, dessert. During a field assessment, product choice is validated by assessing use of products purchased during the ETM task. This proposal will inform policy-makers about the impact banning menthol and mint e-liquids will have on facilitating menthol cigarette smokers switching to e-cigarettes.

详细描述

The study team proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of menthol and mint e-liquids affects product purchasing among menthol cigarette smokers. Adult daily menthol cigarette smokers will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions and one field assessment to evaluate their tobacco use.

Participants will be recruited from Winston-Salem, North Carolina (NC) and the surrounding area using advertisements on public transit, community flyers, and social media. Curbside visits to drop off biosamples and pickup study products will be conducted outside the Wake Forest Tobacco Control Center of Excellence located in Biotech Place in the Innovation Quarter.

The study team anticipates recruiting up to 100 participants to achieve 80 completers. Equal numbers of black and white participants will be enrolled.

研究设计

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

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

  • 21+ years of age
  • Self-report smoking at least 5 cigarettes per day for the past year
  • Self-report smoking menthol cigarette brands > 80% of the time
  • Breathe carbon monoxide (CO) level > 8 ppm Willingness to use other tobacco products during the study
  • Speak, comprehend, and read English sufficiently to complete study procedures
  • Have home access to a computer or tablet with a web camera and internet access

排除标准

  • Currently seeking treatment to quit smoking
  • Self-reported serious medical or psychiatric condition(s) including cardiovascular and chronic respiratory diseases
  • Body temperature > 100.4 F
  • Cold, flu or Novel Coronavirus (COVID-19) symptoms including fever, cough, and runny nose in the past 30 days
  • Currently pregnant, breastfeeding or intending to become pregnant for the duration of the study or unwilling to agree to use adequate protection to avoid pregnancy
  • CO reading > 80 ppm
  • Enrollment stratum (Non-Hispanic, white or Black/African American)

结局指标

主要结局

Total Amount of Combusted Tobacco Purchased

时间窗: Day 6

Total amount of non-menthol cigarettes purchased when menthol cigarettes are not available.

次要结局

  • Total Amount of E-liquid Purchased(Day 3, Day 4, Day 5, Day 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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