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

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Electronic Cigarette Use

Treatments: Other: E-cigarette Flavor; Other: Tobacco Free Nicotine Pouch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05423340

U54CA228110 (U.S. NIH Grant/Contract)

I 2588022

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 3 patient groups

Use Own Brand of Flavored Product

Experimental group

Description:

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

Treatment:

Other: E-cigarette Flavor

Use Provided Tobacco Flavor

Experimental group

Description:

Participants will use a new assigned flavor for 90 days

Treatment:

Other: E-cigarette Flavor

Vaping Abstinence - use "Tobacco Free" Nicotine Pouches

Active Comparator group

Description:

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

Treatment:

Other: Tobacco Free Nicotine Pouch