Addiction Potential, Flavoring Content, and Substitutability of Concept Flavored Cigarillos
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Puff number
研究概览
简要总结
This clinical trial will recruit young adults who currently use cigarillos and examine the smoking behavior and perceptions of different flavored cigarillos, product ingredients/additives impacting these perceptions, and simulated tobacco use outcomes (quitting, switching) in various policy scenarios where different types of flavors are available on the market.
详细描述
This clinical trial will isolate the unique effects of concept descriptors on increased cigarillo use and appeal among experienced young adult cigarillo users. The study will seek to determine the addiction potential of concept flavored cigarillos by examining associations of cigarillo flavor type (concept, characterizing, tobacco) and cigarillo flavoring additives/ingredients to complementary measures of product appeal: subjective effects (e.g., satisfaction, reward, taste), actual smoking behavior (e.g., number of puffs), and simulated cigarillo purchasing, other tobacco product substitution, or quitting under different flavor ban scenarios via an Experimental Tobacco Marketplace (ETM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18 to 24
- •Report past 30-day use of a cigarillo
- •Ability to read English at least an 8th grade level
- •No immediate plans to quit using tobacco
- •At least 1 prior experience with a flavored tobacco product
- •U.S. Citizen or permanent resident of the United States.
排除标准
- •Current use of smoking cessation pharmacotherapy or nicotine replacement therapy;
- •Pregnant, planning to become pregnant, or currently breastfeeding;
- •Past or current clinically significant heart disease or hypertension, or other smoking-related disease that could preclude successful study completion;
- •Inability to abstain from nicotine/tobacco products for at least 12 hours
- •Unwillingness to use the research cigarillos in the lab
研究组 & 干预措施
Concept flavor
Participants will be randomized to smoke one of the three assigned concept flavored cigarillos
干预措施: Cigarillo brand 1 (Other)
Characterizing flavor
Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos
干预措施: Cigarillo brand 1 (Other)
Characterizing flavor
Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos
干预措施: Cigarillo brand 2 (Other)
Tobacco flavor
Participants will be randomized to smoke a tobacco flavored cigarillo
干预措施: Cigarillo brand 2 (Other)
Tobacco flavor
Participants will be randomized to smoke a tobacco flavored cigarillo
干预措施: Cigarillo brand 3 (Other)
Tobacco flavor
Participants will be randomized to smoke a tobacco flavored cigarillo
干预措施: Cigarillo brand 1 (Other)
Concept flavor
Participants will be randomized to smoke one of the three assigned concept flavored cigarillos
干预措施: Cigarillo brand 2 (Other)
Concept flavor
Participants will be randomized to smoke one of the three assigned concept flavored cigarillos
干预措施: Cigarillo brand 3 (Other)
Characterizing flavor
Participants will be randomized to smoke one of the three assigned characterizing flavored cigarillos
干预措施: Cigarillo brand 3 (Other)
结局指标
主要结局
Puff number
时间窗: From enrollment to the end of the final smoking visit, approximately 2 weeks
Number of cigarillo puffs
Subjective reward from smoking
时间窗: From enrollment to the end of the final smoking visit, approximately 2 weeks
Self-reported reward from cigarillo smoking from a questionnaire. This scale has 5 questions with response options ranging from 1 - not at all to 7 - extremely. The score is averaged across the number of items. Higher ratings indicate greater psychological reward
次要结局
未报告次要终点