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

Smoking Behaviors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468333
• Other study ID #: 5R01DA053619
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: University of Nevada, Reno
• Contact: Jennifer Pearson, PhD
• Phone: 7756825005
• Email: jennipearson[@]unr.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking Behaviors

Intervention

Other:
• Cigarette trial
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).

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Desert Research Institute	Reno	Nevada
United States	University of Nevada, Reno	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.