Status:
COMPLETED
Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
University of Rochester
National Institutes of Health (NIH)
Conditions:
Electronic Cigarette Use
Eligibility:
All Genders
21-55 years
Phase:
NA
Brief Summary
This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.
Eligibility Criteria
Inclusion
- ENDS users as determined by: (a) using banned flavored ENDS with nicotine such as fruit, candy, dessert flavors, and/or any product that indicates such flavors (b) using ENDS daily, regularly for the past 6 months (self-reported).
- No smoking tobacco or using smokeless tobacco for the past 6 months.
- Subjects should be free of acute respiratory illness within the proceeding 30 days prior to recruitment (self-reported).
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- After receiving information regarding the NYS flavor ban individuals must not want to quit vaping or stop using their flavored product for the next 90 days.
Exclusion
- Individuals with health conditions and therapies that may affect immune responses and levels of inflammatory markers, including allergic rhinitis, aspirin/NSAID therapy, asthma, immunodeficiency (HIV or other), Guillain-Barre Syndrome, COPD, or fever/respiratory illness within 30 days prior to entry into study (self-reported).
- Pregnant or nursing female participants (self-reported on telephone screener, pregnancy test on Visit#1)
- Unable to communicate in English.
- Unable or unwilling to follow protocol requirements.
- Self-report having active, untreated medical/psychiatric conditions.
- History of serious side effects from nicotine or from any nicotine replacement therapies.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- After receiving information about the NYS flavor ban, participants who report that they are thinking about quitting or stop using their flavor within the next 90 days.
Key Trial Info
Start Date :
June 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT05423340
Start Date
June 12 2022
End Date
October 3 2024
Last Update
January 29 2025
Active Locations (1)
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1
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14206