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临床试验/NCT03897530
NCT03897530终止不适用

Flavored Tobacco Product Regulation: Behavioral Economic Demand, Visual Attention, and Flavored Tobacco Product Availability

Roswell Park Cancer Institute2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2019年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
103
试验地点
2
主要终点
Eye tracking metrics

研究概览

简要总结

This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

详细描述

Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent.
  • Residing in Western New York.
  • Voluntarily provide informed consent to participate in the study.

排除标准

  • Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier.
  • The following special populations will not be included:
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Pregnant women

结局指标

主要结局

Eye tracking metrics

时间窗: At the time of the session , assessed up to 15 months

the interaction of type of cigarette available (menthol versus non-menthol) and type of e-cigarette available (flavors versus unflavored and tobacco), will employ a 2 X 2 repeated measures ANOVA with post-hoc Bonferroni tests to evaluate the outcomes of Q0 (derived initial consumption without cost constraints), α (demand elasticity), the substitution levels, and the eye-tracking metrics.

Cessation of Menthol flavored cigarettes

时间窗: At the time of the session , assessed up to 15 months

Number of flavored cigarettes purchased inThe Experimental Market Place (ETM) will be used to track tobacco purchase behaviors

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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