Clinical trial NCT06816459: Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
Official title: Sensory Evaluation of Cigarettes Claiming Removal of Menthol as a Characterizing Flavor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Menthol smell presence
timeFrame: Up to 1 year
measure: Mint-like smell
timeFrame: Up to 1 year
measure: Cooling sensation during taste test
timeFrame: Up to 1 year
Secondary outcomes:
measure: California (CA) version of the test brand cigarette
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Richard J O'Connor
role: PRINCIPAL_INVESTIGATOR
References: