Electronic Cigarette Use
Conditions
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.
Interventions
OTHERE-cigarette Flavor
Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
OTHERTobacco Free Nicotine Pouch
participants will use tobacco free oral nicotine pouches
Sponsors
Roswell Park Cancer Institute
University of Rochester
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA | Up to around 90 days. | Oxidative stress and inflammation in plasma using ELISA. |
| Respiratory Tract Inflammation Activity | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Recent Flavored Product Use | up to 90 days | 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. |
| Flavor Preference Questionnaire | Up to 90 days | 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. |
| Frequency of Flavored Product Use | 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMaciej Goniewicz, PhD
Roswell Park
Participant flow
Recruitment details
Recruitment started at June 12 2022, and completed at October 03 2024. Recruitments were performed by Roswell Park Cancer Institute, an comprehensive cancer center located at Buffalo NY, in collaboration of University of Rochester, National Institutes of Health (NIH) and National Cancer Institute (NCI).
Pre-assignment details
There were 334 subjects responded to advertisement. Among them, 71 were deemed ineligble, and 100 were eligible but not interested, resulted in 163 protocol enrollment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 31.0 year |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Multi-racial | 3 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 93 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 41 | 0 / 43 |
| other Total, other adverse events | 0 / 47 | 0 / 41 | 0 / 43 |
| serious Total, serious adverse events | 0 / 47 | 0 / 41 | 0 / 43 |
Outcome results
None listed