Clinical trial NCT05423340: Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems
Official title: A Randomized, Parallel-group Open-label Trial of ENDS Users Switching From Flavors of Potentially High-toxicity Profile to Flavors of Potentially Low-toxicity Profile (CRoFT_3.2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2022-06-21
Enrollment: 163
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Risk biomarkers of inflammation and oxidative stress as measured by ELISA
timeFrame: Up to 90 days
measure: Respiratory tract inflammation activity
timeFrame: Up to 90 days
Secondary outcomes:
measure: Amount of recent flavored product use
timeFrame: UP to 90 days
measure: Flavor Preference questionnaire
timeFrame: Up to 90 days
measure: Frequency of flavored product use
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park
name: Maciej Goniewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: