"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 6
- 主要终点
- Difference in total puff volume relative to conventional condition - organic
研究概览
简要总结
Smokers believe that cigarettes with the "natural" or "organic" descriptors are less harmful than cigarettes without these descriptors, but we do not know if these beliefs are associated with how smokers interpret the experience of smoking a "natural" or "organic" cigarette, nor whether these beliefs are predictive of changes in smoking behavior or biological exposures. The primary goal of this study is to examine the relationship between exposure to "natural" or "organic" descriptors in cigarette advertising and smoking health risk expectancies, subjective effects, topography, and biological exposures. To accomplish this goal, we will enroll 250 adult daily cigarette smokers of Natural American Spirit (NAS) or non-NAS brands (125 in each group) in a within-subjects human laboratory study manipulating four expectancy conditions (own brand comparator, "natural" advertising, "organic" advertising, "conventional" advertising).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daily cigarette smoker of 5+ cigarettes/day for at least the past 6 months and consumed 100+ lifetime cigarettes
- •Smoke non-menthol, filtered cigarettes
- •Report daily use of any non-Natural American Spirit (NAS) cigarette brand for the last 30 days (for the non-NAS smoker group), or report daily use of NAS cigarettes for at least 30 days (for the NAS smoker group)
- •Provide exhaled CO level >= 10 ppm at the Session 1 visit
- •Able to communicate fluently in English (speaking, writing, and reading)
- •Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in human participant protections
排除标准
- •Current use of Nat's cigarettes as a preferred brand
- •Plan to quit smoking in the next 30 days and not currently undergoing smoking cessation treatment
- •Are pregnant, planning a pregnancy, and/or lactating
- •Have any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol
- •Have had a serious or unstable disease within the past 6 months (e.g. heart disease, cancer, schizophrenia).
- •Cannot have ever regularly smoked NAS (for the non-NAS group)
结局指标
主要结局
Difference in total puff volume relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Total puff volume as measured by topography device
Difference in salivary aldehyde concentration relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
Difference in salivary aldehyde concentration relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
Difference in perceived chemical content relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in perceived chemical content relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in perceived chemical aftertaste to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in perceived chemical aftertaste to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in total puff volume relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Total puff volume as measured by topography device
Difference in perceived chemical content relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in perceived chemical content relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in total puff volume relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Total puff volume as measured by topography device
Difference in perceived chemical aftertaste to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in perceived chemical aftertaste to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Survey measure
Difference in total puff volume relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Total puff volume as measured by topography device
Difference in salivary aldehyde concentration relative to conventional condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
Difference in salivary aldehyde concentration relative to conventional condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
Difference in perceived chemical content relative to own brand condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
survey measure
Difference in perceived chemical content relative to own brand condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
survey measure
Difference in perceived chemical aftertaste to own brand condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
survey measure
Difference in perceived chemical aftertaste to own brand condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
survey measure
Difference in total puff volume relative to own brand condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
survey measure
Difference in total puff volume relative to own brand condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
total puff volume as measured by a puff topography device
Difference in salivary aldehyde concentration relative to own brand condition - organic
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
Difference in salivary aldehyde concentration relative to own brand condition - natural
时间窗: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
salivary aldehyde concentration measured in saliva
次要结局
未报告次要终点
研究者
Jennifer Pearson
Associate Professor
University of Nevada, Reno
