NCT07107139招募中不适用
Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in sensory response
研究概览
简要总结
This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Age ≥ 21 years of age
- •Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- •Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- •Open to trying a non-combusted oral tobacco product
- •Have the ability to read, write, and communicate in English
- •Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus > $0
- •Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (<8ppm)
- •Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •Age ≥ 21 years of age
- •Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)
- •Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year
- •Open to trying a non-combusted oral tobacco product
- •Have the ability to read, write, and communicate in English
- •Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus > $0
- •Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (<8ppm) .
- •Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
研究组 & 干预措施
Copenhagen group
Active Comparator
Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes.
干预措施: Copenhagen group (Other)
Snus Group
Active Comparator
Participants will place one pouch of snus beween cheek and gums for up to 30 minutes.
干预措施: Snus group (Other)
结局指标
主要结局
Change in sensory response
时间窗: Before viewing study ads and immediatley after viewing
assessed with a 0-100 visual analog scale - anchored by word descriptors at each end.
次要结局
- Change in nicotine boost(Will be collected after 5, 15 and 30 minutes of product use.)
研究者
研究点 (2)
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