Recruiting
Early Phase 1

Menthol Cigarettes

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06816459

Conditions

Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Cigarette smell test

Cigarette Taste Test

Study questionnaires

Study Details

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.

Conditions

Cigarette Smoking-Related Carcinoma

Study ID

NCT06816459

Start date

Oct 14, 2025

Status verified date

Mar, 2026

Completion date

Oct 14, 2027

Anticipated

Primary completion date

Oct 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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).

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.

Study questionnaires

Sensory questionnaires will be administered using a web based application

Primary outcome measure

  • Menthol smell presence [ Time Frame: Up to 1 year ]
  • Mint-like smell [ Time Frame: Up to 1 year ]
  • Cooling sensation during taste test [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Richard J. O'Connor

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-04-06.