Cigarette Smoking-Related CarcinomaEarly Phase 1NCT06816459
Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
A Early Phase 1 study testing Cigarette smell test, Cigarette Taste Test and Study questionnaires in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial tests how well current daily smoking adults can identify flavors of cigarettes. Menthol cigarettes account for 31 percent of cigarettes sold in the United States. Flavors such as menthol play an important role in the start and continued use of tobacco products. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Cigarette smell test, Cigarette Taste Test and Study questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to 14 Oct 2027
- Phase
- Early Phase 1
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 21 years or older
- Current daily smoker of factory-made menthol cigarettes
- General good health (assessed by self-rated health item)
- Completion of Brief Smell Identification Test (B-SIT) with no identification of deficits
Who cannot join
- Daily concurrent use of other tobacco products (e.g., e-cigarettes, cigars, smokeless tobacco)
- Known allergies to mint (peppermint, spearmint), menthol
- Self-reported olfactory or taste deficits
- Pregnant or nursing participants, as indicated by self-report
- History of medications known to interfere with sense of smell
- Positive diagnosis of coronavirus 2019 (COVID-19) within 10 days of enrollment
- Current upper respiratory infection or sinus congestion (e.g., cold, flu, seasonal allergies) (by self report)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Richard J. O'Connor, 716-845-4517, Richard.OConnor@RoswellPark.org
Richard J. O'Connor
About this study
Official title: Sensory Evaluation of Cigarettes Claiming Removal of Menthol as a Characterizing Flavor
This clinical trial tests how well current daily smoking adults can identify flavors of cigarettes. Menthol cigarettes account for 31 percent of cigarettes sold in the United States. Flavors such as menthol play an important role in the start and continued use of tobacco products. Two ways users experience flavor is through smell and taste. Menthol has cooling and numbing properties that can increase perceptions of smoothness and reduce the perceived harshness of smoke. Menthol adds a taste and aroma commonly described as "minty". The effect of menthol flavoring on smoking behavior has been studied. Use of menthol cigarettes has been associated with greater nicotine dependence and is associated with both fewer quit attempts and lower odds of quit success. In 2022, the Food and Drug Administration proposed to restrict the use of menthol as a flavor in cigarettes. Menthol has already been banned in Canada, the United Kingdom and the European Union. In late 2022, a restriction on all flavored tobacco products went into effect in California (CA), prompting the tobacco industry to introduce substitute products that did not contain menthol. It is important to find out whether New York (NY) adult smokers who smoke menthol cigarettes can identify and characterize flavors in the same cigarette brand as sold in NY versus CA following the ban of menthol cigarettes in 2022.
Read the detailed description
PRIMARY OBJECTIVE:
- To convene a consumer panel of adult smokers in New York state (N=24) to assess the smelling properties of a sample of cigarette products sold in the New York and California markets to identify any characterizing flavors.
EXPLORATORY OBJECTIVE:
- To collate consumer-test findings, highlighting quantitative analysis of any characterizing flavors identified, as well as any qualitative insights from the panel about specific products.
OUTLINE: Participants are randomized to 1 of 2 blocks.
BLOCK ALPHA: Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the Brief Smell Identification Test (B-SIT) during session 1, a block alpha cigarette smell test with a total of 16 cigarette products during session 2 and a block alpha cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.
BLOCK BETA: Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block beta cigarette smell test with a total of 16 cigarette products during session 2 and a block beta cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Cigarette smell test, Cigarette Taste Test, Study questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette smell testOther
Undergo cigarette smell test of 16 cigarettes in vials, then rate the overall smell on a 5 pt scale (not at all, a little noticeable, noticeable, clearly/very noticeable , do not know what this is).
Cigarette Taste TestOther
Also called Taste Test
Participants will be present 3 vials , each containing a cigarette and sample in order specified on label, then complete a coolness measure on a 0-100 visual analog scale.
Study questionnairesOther
Sensory questionnaires will be administered using a web based application
| Study group | Role | What they receive |
|---|---|---|
| Block Alpha (block alpha cigarette tests) | Experimental | Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block alpha cigarette smell test with a total of 16 cigarette products during session 2 and a block alpha cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity. Receives: Other: Cigarette smell test; Other: Cigarette Taste Test; Other: Study questionnaires |
| Block Beta (block beta cigarette tests) | Experimental | Participants complete 3 testing sessions, each session lasting 1 to 2 hours and each session at least 48 hours apart but no more than 1 week apart. Participants undergo the B-SIT during session 1, a block beta cigarette smell test with a total of 16 cigarette products during session 2 and a block beta cigarette taste test with a set of 3 cigarettes during session 3. Testing sessions are completed in the absence of illness or unacceptable toxicity. Receives: Other: Cigarette smell test; Other: Cigarette Taste Test; Other: Study questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menthol smell presence
Will evaluate ratings of menthol smell presence (0-5 scale). Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.
Measured: Up to 1 year
Mint-like smell
Will evaluate ratings of mint-like smell (0-4 scale). Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.
Measured: Up to 1 year
Cooling sensation during taste test
Will be assessed using a self-rated coolness measure on a 0-100 visual analog scale. Data will be analyzed under the generalized linear model approach, a flexible regression-based approach that allows for different distributional assumptions of the dependent variable, and for different link functions to describe the relationship between the independent and dependent variable. These models utilize maximum likelihood (iteratively reweighted least squares) estimation. The generalized estimating equation extension allows for modeling of sample-averaged repeated measures within individuals.
Measured: Up to 1 year
Secondary outcomes (1)
California (CA) version of the test brand cigarette
Will evaluate proportion correctly identifying the CA version of the test brand cigarette.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start14 Oct 2025
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J O'Connor, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816459
- Sponsor's protocol ID
- I-3571524
- Other IDs
- NCI-2025-00202, I-3571524
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No