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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorRoswell Park Cancer Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cigarette smell test

    Other intervention

    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 intervention

    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 questionnaires

    Other intervention

    Sensory questionnaires will be administered using a web based application

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Block Alpha (block alpha cigarette tests)Experimental treatment 3 interventions
Group B: Block Beta (block beta cigarette tests)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 year
2

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.

Time frame
Up to 1 year
3

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.

Time frame
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.

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

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