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临床试验/NCT03612349
NCT03612349Unknown不适用

Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

Brown University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Total amount of combusted tobacco purchased in mg of nicotine.

研究概览

简要总结

In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.

详细描述

We will enroll 60 smokers who will complete four lab sessions and two field assessments. Participants meeting initial eligibility criteria over the phone will complete an in-person screening visit. Breath carbon monoxide and alcohol tests will be collected. Participants will answer questionnaires on the computer and via interview about their tobacco use and medical history. Eligible participants will remain in the lab to complete additional baseline questionnaires and will be given the opportunity to sample alternative tobacco products, such as LCCs, smokeless tobacco, electronic cigarettes, and nicotine replacement.

During the next two lab sessions, participants will complete a behavioral economics assessment, the Experimental Tobacco Marketplace task, designed to simulate purchasing tobacco products online. Participants will be given 'coupons' to obtain tobacco products from the online experimental marketplace. After these lab sessions, participants will be provided with the tobacco products they selected from the online experimental marketplace to use during 3-day field assessments to validate the task. Participants will be told to only use tobacco products provided by the lab during the field assessments. At both lab sessions, participants will complete questionnaires about their tobacco use, mood, and reactions to the alternative tobacco products. At the final lab session, a qualitative interview will be conducted to learn more about the participants' experiences selecting and using tobacco products.

研究设计

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

盲法说明

There is no masking since participants experience both marketplace conditions.

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

  • Ages 18 and older
  • Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
  • Self-report smoking a menthol cigarette brand
  • Must report use of an alternative tobacco product(s) at least once in the past month
  • Breath CO levels > 8 ppm (if < 8 ppm, then NicAlert Strip = 6)
  • Speak, comprehend, and read English well enough to complete study procedures

排除标准

  • Breath alcohol level > 0.01 ng/ml
  • Intention to quit smoking in the next 30 days
  • Self-reported serious medical or psychiatric conditions during the past 12 months including:
  • heart attack
  • blood clots in the arms or legs for which the individual is undergoing active medical treatment
  • cancer requiring active chemotherapy or radiation therapy
  • chronic obstructive pulmonary disease
  • schizophrenia
  • Pregnant or breastfeeding
  • CO reading > 80 ppm
  • Enrollment stratum (white or African-American/black) is full

研究组 & 干预措施

Condition 1: All Products

Other

Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, all tobacco products are available in menthol and non-menthol flavors.

干预措施: Experimental Tobacco Marketplace Task (Behavioral)

Condition 2: No menthol LCCs

Other

Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, the online tobacco marketplace does not include menthol flavored little cigars and cigarillos.

干预措施: Experimental Tobacco Marketplace Task (Behavioral)

结局指标

主要结局

Total amount of combusted tobacco purchased in mg of nicotine.

时间窗: through study completion, an average of 2-weeks.

How much combusted tobacco is purchased by the participants.

次要结局

  • Tobacco Product Demand Curves(through study completion, an average of 2-weeks.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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