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

NCT ID: NCT06816459

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2026-02-28

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.

Conditions

Cigarette Smoking-Related Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Block Alpha (block alpha cigarette tests)

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.

Group Type: EXPERIMENTAL

Cigarette smell test

Intervention Type: 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

Intervention Type: 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.

Study questionnaires

Intervention Type: OTHER

Sensory questionnaires will be administered using a web based application

Block Beta (block beta cigarette tests)

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.

Group Type: EXPERIMENTAL

Cigarette smell test

Intervention Type: 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

Intervention Type: 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.

Study questionnaires

Intervention Type: OTHER

Sensory questionnaires will be administered using a web based application

Interventions

Cigarette 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).

Intervention Type: OTHER

Cigarette 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.

Intervention Type: OTHER

Study questionnaires

Sensory questionnaires will be administered using a web based application

Intervention Type: OTHER

Other Intervention Names

Taste Test

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard J O'Connor

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Richard J. O'Connor

Role: primary

Richard.OConnor@RoswellPark.org

716-845-4517

Other Identifiers

NCI-2025-00202

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3571524

Identifier Type: OTHER

Identifier Source: secondary_id

I-3571524

Identifier Type: -

Identifier Source: org_study_id