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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
163
Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
participants will use tobacco free oral nicotine pouches
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Risk biomarkers of inflammation and oxidative stress as measured by ELISA
Oxidative stress and inflammation in plasma using ELISA . A quantitative measure of expression (units:pg/mg) will be produced.
Time frame: Up to 90 days
Respiratory tract inflammation activity
Exhaled Nitric Oxide (FeNo)l be measured in participants' breath using a FDA cleared monitor NIOX VERO (Aerocrine) according to ATS guidelines. FeNO has been used to monitor airway inflammation to account for persistent and/or high allergen exposure as a factor associated with higher levels of FeNO
Time frame: Up to 90 days
Amount of recent flavored product use
Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use,
Time frame: UP to 90 days
Flavor Preference questionnaire
Personal flavor questionnaire to determine flavor preference when using ENDS.
Time frame: Up to 90 days
Frequency of flavored product use
Questions from Wave 1 Adult PATH Survey to measure use and regularity of use flavored products
Time frame: Up to 90 days
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