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

NCT05423340 | Completed

• 2 other identifiers: I 2588022U54CA228110
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarette Use

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Up to 90 days

Secondary Outcomes (3)

• Amount of recent flavored product use

  UP to 90 days

• Flavor Preference questionnaire

  Up to 90 days

• Frequency of flavored product use

  Up to 90 days

Study Arms (3)

Use Own Brand of Flavored Product

EXPERIMENTAL

Participants will use their current flavor of e cigarettes for 90 days

Other: E-cigarette Flavor

Use Provided Tobacco Flavor

EXPERIMENTAL

Participants will use a new assigned flavor for 90 days

Other: E-cigarette Flavor

Vaping Abstinence - use "Tobacco Free" Nicotine Pouches

ACTIVE COMPARATOR

Participants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.

Other: Tobacco Free Nicotine Pouch

Interventions

E-cigarette Flavor OTHER

Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid

Use Own Brand of Flavored Product; Use Provided Tobacco Flavor

Tobacco Free Nicotine Pouch OTHER

participants will use tobacco free oral nicotine pouches

Vaping Abstinence - use "Tobacco Free" Nicotine Pouches

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• University of Rochester: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14206, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Maciej Goniewicz, PhD

  Roswell Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 21, 2022
• Study Start: June 12, 2022
• Primary Completion: October 3, 2024
• Study Completion: October 3, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (1)