Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Sy… (NCT05423340) | Clinical Trial Compass
CompletedNot Applicable
Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems
United States163 participantsStarted 2022-06-12
Plain-language 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.
Who can participate
Age range21 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 nicoti…
What they're measuring
1
Risk biomarkers of inflammation and oxidative stress as measured by ELISA