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

Early Phase 1

Recruiting

• Conditions: Cigarette Smoking-Related Carcinoma

• Registration Number: NCT06816459
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-22
• Study Start: 2025-07-28
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Menthol smell presence	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.
Mint-like smell	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.
Cooling sensation during taste test	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 Outcome Measures

Name	Time	Method
California (CA) version of the test brand cigarette	Up to 1 year	Will evaluate proportion correctly identifying the CA version of the test brand cigarette.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States