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Completed

NCT Number: NCT05468333

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

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).

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Key information

Conditions

Smoking Behaviors Behavior Smoking

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Desert Research Institute, Reno, Nevada, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Difference in perceived chemical content relative to conventional condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    Survey measure

  2. Difference in perceived chemical content relative to conventional condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    Survey measure

  3. Difference in perceived chemical aftertaste to conventional condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    Survey measure

  4. Difference in perceived chemical aftertaste to conventional condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    Survey measure

  5. Difference in total puff volume relative to conventional condition - natural

    Time frame: 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

  6. Difference in total puff volume relative to conventional condition - organic

    Time frame: 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

  7. Difference in salivary aldehyde concentration relative to conventional condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    salivary aldehyde concentration measured in saliva

  8. Difference in salivary aldehyde concentration relative to conventional condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    salivary aldehyde concentration measured in saliva

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

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    survey measure

  10. Difference in perceived chemical content relative to own brand condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    survey measure

  11. Difference in perceived chemical aftertaste to own brand condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    survey measure

  12. Difference in perceived chemical aftertaste to own brand condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    survey measure

  13. Difference in total puff volume relative to own brand condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    survey measure

  14. Difference in total puff volume relative to own brand condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    total puff volume as measured by a puff topography device

  15. Difference in salivary aldehyde concentration relative to own brand condition - organic

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    salivary aldehyde concentration measured in saliva

  16. Difference in salivary aldehyde concentration relative to own brand condition - natural

    Time frame: no sooner than 1 day after prior study visit and up to 3 months after first study visit.

    salivary aldehyde concentration measured in saliva

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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