NCT06816459 Sensory Tests of Cigarettes for Identification of Flavors in Current Daily Smoking Adults
| NCT ID | NCT06816459 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Cigarette Smoking-Related Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2027-10-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-10-14 with a primary completion date of 2027-10-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Aged 21 years or older * 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)
Contact & Investigator
Richard J O'Connor
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT06816459 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Cigarette Smoking-Related Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06816459 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06816459 currently recruiting?
Yes, NCT06816459 is actively recruiting participants. Visit ClinicalTrials.gov or contact Roswell Park Cancer Institute to inquire about joining.
Where is the NCT06816459 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06816459 clinical trial?
NCT06816459 is sponsored by Roswell Park Cancer Institute. The principal investigator is Richard J O'Connor at Roswell Park Cancer Institute. The trial plans to enroll 30 participants.