Sensory Tests of Cigarettes for Flavor Identification

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Smell-interfering medications

Disqualifiers: Other tobacco use, Mint allergies, Olfactory deficits, Pregnant, COVID-19, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how well adults who smoke menthol cigarettes daily can identify cigarette flavors, especially following recent menthol bans in some areas. Researchers seek to understand the role of flavor in smoking habits, with a particular focus on smell and taste. Participants will engage in sessions testing their ability to identify cigarette flavors through smell and taste tests. Individuals who currently smoke menthol cigarettes daily and are in good health may be suitable for this trial. As an Early Phase 1 trial, this study focuses on understanding participants' initial reactions and sensory perceptions, offering a unique opportunity to contribute to groundbreaking research on smoking habits.

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 prior data suggests that these cigarette tests are safe?

Research on the safety of sensory tests for cigarettes, such as smell and taste tests, does not provide specific safety details for these activities. However, these tests involve smokers who are already accustomed to tobacco products.

Studies have shown that tobacco use is linked to problems with taste and smell, meaning smokers might notice changes in these senses. For example, smokers often have reduced taste sensitivity compared to non-smokers, and higher nicotine addiction can further diminish taste sensitivity. These changes result from smoking itself, not the sensory tests.

The trial is in an early stage, focusing on basic safety and understanding how the tests work. While specific safety data for these tests is not yet available, their inclusion in an early-stage trial suggests they are generally considered safe enough to begin testing with participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore how people identify cigarette flavors through smell and taste tests. Unlike traditional studies that might focus on the health effects of smoking, this trial digs into the sensory perception of cigarettes. By using specific smell and taste tests with various cigarette products, researchers hope to gain insights into how these senses contribute to the overall smoking experience. This could lead to a better understanding of smoking behaviors and potentially inform future tobacco control strategies.

What evidence suggests that this trial's tests could be effective for flavor identification in cigarettes?

Studies have shown that smoking can affect taste and smell. Smokers often experience a reduced ability to taste, particularly with menthol cigarettes. Menthol alters taste by providing a cooling effect that smooths the smoke. Research indicates that smokers may also struggle to detect smells, affecting their perception of cigarette flavors. This trial will compare two testing approaches: the Block Alpha and Block Beta cigarette tests. Each method will evaluate smokers' ability to identify different flavors, considering changes in taste and smell. Understanding these effects can help explain smoking habits and preferences. ^{1 5 6 7 8}

Who Is on the Research Team?

Richard J O'Connor

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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

Exclusion Criteria

I use tobacco products daily.

Known allergies to mint (peppermint, spearmint), menthol

Pregnant or nursing participants, as indicated by self-report

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Block Beta (block beta cigarette tests) Experimental Treatment 3 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 Treatment 3 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.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06816459

Sensory Tests of Cigarettes for Identification of Flavors in ... This clinical trial tests how well current daily smoking adults can identify flavors of cigarettes. Menthol cigarettes account for 31 percent of cigarettes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10851189/

An assessment of taste and smell disorders using 2021 ... This study aims to assess the relationship between use of tobacco products and taste and smell disorders.

3. tobaccopreventioncessation.com tobaccopreventioncessation.com/Evaluation-of-the-intensity-of-cigarette-odors-based-on-the-nperception-of-consumers,162103,0,2.html

Evaluation of the intensity of cigarette odors based on ... The main results show that there is a general decrease of the perceived odor intensity with age, for both males and females. Sex also affects odor perception, ...

4. withpower.com withpower.com/trial/sensory-tests-of-cigarettes-for-flavor-identification-c5491

Sensory Tests of Cigarettes for Flavor Identification This clinical trial tests how well current daily smoking adults can identify flavors of cigarettes. Menthol cigarettes account for 31 percent of cigarettes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6731037/

Smoking and Olfactory Dysfunction: a Systematic Literature ... A systematic review and meta-analysis of the literature examining the association between tobacco smoking and olfactory function in humans.

6. nature.com nature.com/articles/s41598-022-06047-4

Pilot study to determine differences in breath odour ... In this pilot study, we aimed to determine differences in breath odour between cigarette smokers (CSs) and e-cigarette consumers (ECs) in 33 healthy subjects.

7. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Tobacco-use-and-chemosensory-impairments-among-current-nadult-tobacco-users-in-the,94202,0,2.html

Tobacco use and chemosensory impairments among ... Introduction: Among US adults 40 years and older, about 23% report problems with their ability to smell, and 19% report problems with their ability to taste ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0031938498001930

Olfactory Thresholds for Nicotine and Menthol in Smokers ... The results of the present study indicate that current smokers have a higher olfactory threshold for nicotine than do nonsmokers.