Clinical trial NCT05468333: "Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
Official title: "Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 184
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Difference in perceived chemical content relative to conventional condition - natural
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in perceived chemical content relative to conventional condition - organic
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in perceived chemical aftertaste to conventional condition - natural
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in perceived chemical aftertaste to conventional condition - organic
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in total puff volume relative to conventional condition - natural
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in total puff volume relative to conventional condition - organic
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in salivary aldehyde concentration relative to conventional condition - natural
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
measure: Difference in salivary aldehyde concentration relative to conventional condition - organic
timeFrame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: Desert Research Institute
state: Nevada
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: