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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Electronic Cigarette Use
• Intervention / Treatment: Other: E-cigarette Flavor; Other: Tobacco Free Nicotine Pouch

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maciej Goniewicz, PhD; Phone Number: 716-845-2300; Email: Maciej.Goniewicz@roswellpark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14206
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Contact: Maciej Goniewicz, MD; Phone Number: 800-767-9355; Email: askroswell@roswellpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use Own Brand of Flavored Product; Participants will use their current flavor of e cigarettes for 90 days	Other: E-cigarette Flavor; Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
Experimental: Use Provided Tobacco Flavor; Participants will use a new assigned flavor for 90 days	Other: E-cigarette Flavor; Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
Active Comparator: Vaping Abstinence - use "Tobacco Free" Nicotine Pouches; 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; participants will use tobacco free oral nicotine pouches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Flavor Preference questionnaire	Personal flavor questionnaire to determine flavor preference when using ENDS.	Up to 90 days
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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); University of Rochester
• Investigators: Principal Investigator: Maciej Goniewicz, PhD, Roswell Park

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2022
• Primary Completion (Estimated): June 12, 2025
• Study Completion (Estimated): June 12, 2025

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: I 2588022; U54CA228110 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No