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临床试验/NCT07010601
NCT07010601已完成不适用

U54 Pilot: Comparing Tobacco Product Susceptibility and Product Substitution by Relative Rurality and Alcohol Use

Mark J Rzeszutek, PhD2 个研究点 分布在 1 个国家目标入组 737 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
737
试验地点
2
主要终点
Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace

研究概览

简要总结

A high priority research area for the Food and Drug Administration Center for Tobacco Products (FDA CTP) is determining who will start using tobacco products and who will stop using tobacco products. A population that has a disproportionately high amount of tobacco use are people living in rural areas. This indicates that some aspect of rurality is related to tobacco product susceptibility and decreased tobacco cessation rates. People in rural areas also typically have higher rates of alcohol use, which is also associated with higher tobacco use and decreased tobacco cessation rates. The purpose of this study is to (1) examine how rurality and alcohol use may affect susceptibility to existing and novel tobacco products and (2) examine how rurality and alcohol use may affect likelihood for tobacco users to substitute to tobacco cessation products. To accomplish this, the investigators will use behavioral economic measures to assess how people respond to novel tobacco products (high and low nicotine, flavored and unflavored), as well as use the experimental tobacco marketplace to determine how current users might switch to products associated with cessation. Because rurality is a spectrum, the investigators will be using an index of relative rurality (IRR) to better quantify how rurality and alcohol use affect these tobacco-related behaviors.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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 or older
  • Smoke cigarettes or use e-cigarettes 25 or more days a month
  • Cigarette/E-Cigarette Non-Users
  • Inclusion Criteria:
  • 21 years of age or older
  • Do not report using an e-cigarette or cigarette in the past month
  • Risky Alcohol Users
  • Inclusion Criteria:
  • 21 years of age or older
  • A score of 8 or higher on the Alcohol Use Disorder Identification Test
  • Non-Risky Alcohol Users
  • Inclusion Criteria:
  • 21 years of age or older
  • A score of 7 or lower on the Alcohol Use Disorder Identification Test
  • Inclusion Criteria:
  • Located in the USA
  • At least 100 complete studies on Prolific
  • Exclusion Critera:
  • Failing attention checks during the screener

排除标准

  • 未提供

结局指标

主要结局

Alternative Product Purchasing as a Function of Change in Price of Cigarettes and/or E-Cigarettes in the Experimental Tobacco Marketplace

时间窗: Assessed at study week 0

Cigarette and e-cigarette users will complete different experimental tobacco marketplace scenarios. Alternative product purchasing (substitution) for different nicotine products as a function of increasing price of cigarettes/e-cigarettes will be measured with non-linear mixed-effects cross-commodity demand equations that determine the magnitude and direction of product substitution as a function of price increases of cigarettes and/or e-cigarettes. A higher magnitude indicates a larger change in product purchasing as a function of the ascending price item, where direction determines if the commodity was a complement to or substitute of the ascending price item(s). In the case of failures of non-linear model fitting, linear models will be used to determine product substitution based on intercept (initial purchasing) and slope (degree of substitution).

Demand Intensity and Price Sensitivity for Hypothetical Nicotine Products

时间窗: Assessed at study week 0

Likelihood to purchase and consume hypothetical nicotine products and sensitivity to cost of different product categories, flavors, and nicotine combinations will be assessed in all groups. Hypothetical demand will be assessed using non-linear mixed-effects modeling to obtain estimates of demand intensity and price sensitivity for these hypothetical products. Higher intensity and lower price sensitivity are indicators for higher subjective value and likelihood to try these novel products.

次要结局

未报告次要终点

研究者

发起方
Mark J Rzeszutek, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark J Rzeszutek, PhD

Principal Investigator

University of Kentucky

研究点 (2)

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