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

NCT05468333 | Completed

• 1 other identifier: 5R01DA053619
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

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).

Conditions

Smoking Behaviors

Outcome Measures

Primary Outcomes (16)

• 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.

• Difference in perceived chemical content relative to own brand 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 own brand 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 own brand 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 own brand 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 own brand condition - natural

  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 own brand condition - organic

  total puff volume as measured by a puff 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 own brand 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.

• Difference in salivary aldehyde concentration relative to own brand 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.

Study Arms (1)

Main arm

EXPERIMENTAL

All participants received the same intervention; however, the order of the intervention was randomized to reduce the risk of order effects.

Other: Cigarette trial

Interventions

Cigarette trial OTHER

Participants were told that they were participating in market research for a new tobacco company called "Capital Tobacco." They were told that they were going to try three different cigarettes for the new company -- a conventional cigarette, a natural cigarette, and an organic cigarette -- and provide the research team with their impressions about the advertising and the smoking experience for each product. We also told them were were studying whether smoking these different types of cigarettes changed their exposure to chemicals in cigarette smoke. The intervention consisted of showing participants conventional, natural, and organic versions of a mailer and reading them a brief description of the brand. In reality, participants were smoking the same cigarette 3 times.

Main arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: Self-identification as a man or woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nevada, Reno: lead

Study Sites (3)

Desert Research Institute

Reno, Nevada, 89512, United States

Location

University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 21, 2022
• Study Start: January 20, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)