Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems

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 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.