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临床试验/NCT05468333
NCT05468333已完成不适用

"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers

University of Nevada, Reno6 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2022年1月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Pearson

Associate Professor

University of Nevada, Reno

研究点 (6)

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