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

Electronic Cigarette Use Clinical Trial

— CRoFT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423340
• Other study ID #: I 2588022
• Secondary ID: U54CA228110
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2022
• Est. completion date: June 12, 2025

Study information

• Verified date: June 2023
• Source: Roswell Park Cancer Institute
• Contact: Maciej Goniewicz, PhD
• Phone: 716-845-2300
• Email: Maciej.Goniewicz[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: June 12, 2025
• Est. primary completion date: June 12, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarette Use

Intervention

Other:
• E-cigarette Flavor
Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
• Tobacco Free Nicotine Pouch
participants will use tobacco free oral nicotine pouches

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (4)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI), National Institutes of Health (NIH), University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Amount of recent flavored product use	Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use,	UP to 90 days
Secondary	Flavor Preference questionnaire	Personal flavor questionnaire to determine flavor preference when using ENDS.	Up to 90 days
Secondary	Frequency of flavored product use	Questions from Wave 1 Adult PATH Survey to measure use and regularity of use flavored products	Up to 90 days