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NCT Number: NCT06816459

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

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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Richard J. O'Connor

CONTACT

[email protected]

716-845-4517

Richard J. O'Connor

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Cigarette smell test

Other

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 Test

Other

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.

Other names: Taste Test

Study questionnaires

Other

Sensory questionnaires will be administered using a web based application

Primary outcomes

  1. Menthol smell presence

    Time frame: Up to 1 year

    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.

  2. Mint-like smell

    Time frame: Up to 1 year

    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.

  3. Cooling sensation during taste test

    Time frame: Up to 1 year

    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.

Secondary outcomes

  1. California (CA) version of the test brand cigarette

    Time frame: Up to 1 year

    Will evaluate proportion correctly identifying the CA version of the test brand cigarette.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Apr 6, 2026

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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