Use Provided Tobacco Flavor for Electronic Cigarette Use

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Roswell Park Comprehensive Cancer Center, Buffalo, NY
Electronic Cigarette Use
E-cigarette Flavor - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 90 days

UP to 90 days
Amount of recent flavored product use
Up to 90 days
Flavor Preference questionnaire
Flavor preference
Frequency of flavored product use
Respiratory tract inflammation activity
Risk biomarkers of inflammation and oxidative stress as measured by ELISA

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Vaping Abstinence - use "Tobacco Free" Nicotine Pouches
1 of 3
Use Provided Tobacco Flavor
1 of 3
Use Own Brand of Flavored Product
1 of 3
Active Control
Experimental Treatment

216 Total Participants · 3 Treatment Groups

Primary Treatment: Use Provided Tobacco Flavor · No Placebo Group · N/A

Use Provided Tobacco Flavor
Other
Experimental Group · 1 Intervention: E-cigarette Flavor · Intervention Types: Other
Use Own Brand of Flavored Product
Other
Experimental Group · 1 Intervention: E-cigarette Flavor · Intervention Types: Other
Vaping Abstinence - use "Tobacco Free" Nicotine Pouches
Other
ActiveComparator Group · 1 Intervention: Tobacco Free Nicotine Pouch · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 90 days
Closest Location: Roswell Park Comprehensive Cancer Center · Buffalo, NY
2020First Recorded Clinical Trial
1 TrialsResearching Electronic Cigarette Use
15 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have not smoked tobacco or used smokeless tobacco for the past 6 months.
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.
Subjects should be free of acute respiratory illness within the preceding 30 days.
You 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.