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

Study Overview
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Brief Summary
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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).

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

Conditions
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Smoking Behaviors

Intervention / Treatment
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* Other: Cigarette trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main arm<br>Per NIH Program Official, this is not an ACT and thus full protocol info is not required at this time. | Other: Cigarette trial<br>* Per NIH Program Official, this is not an ACT and thus full protocol info is not required at this time (and would be detrimental to the study if details were disclosed during recruitment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in perceived chemical content relative to conventional condition - natural | Survey measure | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in perceived chemical content relative to conventional condition - organic | Survey measure | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in perceived chemical aftertaste to conventional condition - natural | Survey measure | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in perceived chemical aftertaste to conventional condition - organic | Survey measure | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in total puff volume relative to conventional condition - natural | Total puff volume as measured by topography device | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in total puff volume relative to conventional condition - organic | Total puff volume as measured by topography device | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in salivary aldehyde concentration relative to conventional condition - natural | salivary aldehyde concentration measured in saliva | no sooner than 1 day after prior study visit and up to 3 months after first study visit. | 
| Difference in salivary aldehyde concentration relative to conventional condition - organic | salivary aldehyde concentration measured in saliva | no sooner than 1 day after prior study visit and up to 3 months after first study visit. |