Smoking BehaviorsNCT05468333
"Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
A study testing Cigarette trial in people with Smoking Behaviors, run by University of Nevada, Reno at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Cigarette trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Desert Research Institute
Reno, Nevada, 89512
University of Nevada, Reno
Reno, Nevada, 89557
About this study
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
- Being tested
- Cigarette trial
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette trialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | All participants received the same intervention; however, the order of the intervention was randomized to reduce the risk of order effects. Receives: Other: Cigarette trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in perceived chemical content relative to conventional condition - natural
Survey measure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: no sooner than 1 day after prior study visit and up to 3 months after first study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start20 Jan 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Pearson, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468333
- Sponsor's protocol ID
- 5R01DA053619
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Natural" and "Organic" Cigarette Descriptors: Association With Expectancies, Subjective Effects, Topography, and Biomarkers of Exposure Among Daily Smokers
- ClinicalTrials.gov ID
- NCT05468333
- Acronym / sponsor ID
- 5R01DA053619
- Conditions
- Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main arm | Experimental | Other: Cigarette trialAll participants received the same intervention; however, the order of the intervention was randomized to reduce the risk of order effects. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarette trialParticipants 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. | Other | Main arm |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarette trial in people with Smoking Behaviors, run by University of Nevada, Reno at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.