30 Participants Needed

Sensory Tests of Cigarettes for Flavor Identification

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it excludes those with a history of medications known to interfere with the sense of smell.

What data supports the effectiveness of the treatment Cigarette smell test and Cigarette Taste Test for flavor identification?

Research shows that chronic smokers often experience changes in their ability to smell and taste, which can affect how they perceive cigarette flavors. Smokers, especially those who prefer menthol cigarettes, may have heightened taste sensitivity, which could influence their ability to identify flavors in cigarettes.12345

Is the sensory test of cigarettes for flavor identification safe for humans?

The research does not provide specific safety data for sensory tests of cigarettes for flavor identification, but it does indicate that chronic smoking can alter sensory functions like smell and taste, which may be relevant to consider for participants.13467

How does the sensory test of cigarettes for flavor identification differ from other treatments for flavor regulation in tobacco products?

This treatment is unique because it combines sensory and chemical analysis to determine the human odor difference threshold for flavor additives in tobacco, which is important for regulatory purposes. Unlike other treatments, it provides a simple and fast method to quantify specific flavor components, such as menthol, in tobacco products.168910

What is the purpose of 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.

Research Team

RJ

Richard J O'Connor

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults who smoke daily and are interested in participating in sensory tests to identify cigarette flavors. Participants should be current smokers with a regular habit, as the study focuses on their ability to detect menthol and other flavors through taste and smell.

Inclusion Criteria

I currently smoke menthol cigarettes every day.
I consider myself to be in good health.
Completion of Brief Smell Identification Test (B-SIT) with no identification of deficits
See 1 more

Exclusion Criteria

I use tobacco products daily.
Known allergies to mint (peppermint, spearmint), menthol
Pregnant or nursing participants, as indicated by self-report
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing Sessions

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. Sessions include the Brief Smell Identification Test, cigarette smell tests, and cigarette taste tests.

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing sessions

4 weeks

Treatment Details

Interventions

  • Cigarette smell test
  • Cigarette Taste Test
Trial Overview The study investigates how well adult daily smokers can identify flavors in cigarettes by conducting taste and smell tests, along with questionnaires. It aims to understand the impact of flavor bans by comparing perceptions of the same brand sold in New York versus California post-menthol ban.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Block Beta (block beta cigarette tests)Experimental Treatment3 Interventions
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 II: Block Alpha (block alpha cigarette tests)Experimental Treatment3 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

References

Heightened olfactory dysfunction and oral irritation among chronic smokers and heightened propylthiouracil (PROP) bitterness among menthol smokers. [2020]
Effects of smoking on taste: assessment with contact endoscopy and taste strips. [2010]
Evaluation of the intensity of cigarette odors based on the perception of consumers. [2023]
Cigarettes with different nicotine levels affect sensory perception and levels of biomarkers of exposure in adult smokers. [2018]
The effects of foods, beverages, and other factors on cigarette palatability. [2016]
The Sensory Difference Threshold of Menthol Odor in Flavored Tobacco Determined by Combining Sensory and Chemical Analysis. [2023]
Lack of effect of menthol level and type on smokers' estimated mouth level exposures to tar and nicotine and perceived sensory characteristics of cigarette smoke. [2015]
Sensory methods to evaluate perception of flavours in tobacco and other nicotine-containing products: a review. [2023]
Sensory Effects of Menthol and Nicotine in an E-Cigarette. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Acute effects of flavored Black and mild cigars among young adult cigarette smokers. [2023]
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