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Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults

Sensory Evaluation of Cigarettes Claiming Removal of Menthol as a Characterizing Flavor

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816459
Enrollment
30
Registered
2025-02-10
Start date
2025-10-14
Completion date
2027-10-14
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking-Related Carcinoma

Brief 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. 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.

Detailed description

PRIMARY OBJECTIVE: I. 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: I. 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.

Interventions

OTHERCigarette smell test

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).

OTHERCigarette 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.

Sensory questionnaires will be administered using a web based application

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants are blinded to brand and condition

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 21-55 years old * 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Menthol smell presenceUp to 1 yearWill 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.
Mint-like smellUp to 1 yearWill 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.
Cooling sensation during taste testUp to 1 yearWill 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.

Secondary

MeasureTime frameDescription
California (CA) version of the test brand cigaretteUp to 1 yearWill evaluate proportion correctly identifying the CA version of the test brand cigarette.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRichard J O'Connor

Roswell Park Cancer Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026