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.
Time frame: Up to around 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: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days
Amount of Recent Flavored Product Use
Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use. Amount of recent flavored product use were assessed throughout the entire study and estimates per month. The average (with standard deviation) amount of volume (mL) of e-liquid purchased by participants throughout the entire study were reported.
Time frame: up to 90 days
Flavor Preference Questionnaire
Personal flavor questionnaire to determine flavor preference when using ENDS. Absolute favorite flavor of all most commonly used flavors (i.e. Alcohol, Candy, Chocolate, Clove or Spice, Fruit, Menthol or Mint, Other, Tobacco, Unflavored) are reported.
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, with the scores ranging of 0 and 100. Data is presented on the percentage of days between sessions participants reported use of product as median and inter-quartile range (IQR). A non-parametric Kruskal-Wallis test followed by Dunn's Multiple Comparisons with Benjamnini-Hochberg adjustment was also performed for each product to assess differences between study groups within a visit, and between visits within a study group.
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Time frame: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days