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

Not Applicable

Completed

• Conditions: Smoking Behaviors
• Interventions: Other: Cigarette trial

• Registration Number: NCT05468333
• Lead Sponsor: University of Nevada, Reno

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main arm	Cigarette trial	Per NIH Program Official, this is not an ACT and thus full protocol info is not required at this time.

Primary Outcome Measures

Name	Time	Method
Difference in total puff volume relative to conventional condition - organic	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 - organic	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 total puff volume relative to conventional condition - natural	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	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	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	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	no sooner than 1 day after prior study visit and up to 3 months after first study visit.	Survey measure
Difference in salivary aldehyde concentration relative to conventional condition - natural	no sooner than 1 day after prior study visit and up to 3 months after first study visit.	salivary aldehyde concentration measured in saliva

Trial Locations

Locations (3)

Desert Research Institute; 🇺🇸 Reno, Nevada, United States

University of Nevada, Reno; 🇺🇸 Reno, Nevada, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States