Electronic Cigarette UseCRoFTNCT05423340

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

A study testing E-cigarette Flavor and Tobacco Free Nicotine Pouch in people with Electronic Cigarette Use, run by Roswell Park Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use
What is being tested?: E-cigarette Flavor and Tobacco Free Nicotine Pouch
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2022to 3 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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 locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14206

Other trials in United States

About this study

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)

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
Being tested: E-cigarette Flavor, Tobacco Free Nicotine Pouch
Medical subject headings: Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E-cigarette FlavorOther
Participants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid
Tobacco Free Nicotine PouchOther
participants will use tobacco free oral nicotine pouches

Study groups in NCT05423340
Study group	Role	What they receive
Use Own Brand of Flavored Product	Experimental	Participants will use their current flavor of e cigarettes for 90 days Receives: Other: E-cigarette Flavor
Use Provided Tobacco Flavor	Experimental	Participants will use a new assigned flavor for 90 days Receives: 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. Receives: Other: Tobacco Free Nicotine Pouch

What is being measured

The primary outcome is the main question the study is designed to answer.

Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
Oxidative stress and inflammation in plasma using ELISA.
Measured: Up to around 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
Measured: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days

Secondary outcomes (3)

Amount of Recent Flavored Product Use
Assessed using the PhenX Toolkit which tracks tobacco use and asks subjects to retrospectively estimate product use. Amount of recent flavored product use were assessed throughout the entire study and estimates per month. The average (with standard deviation) amount of volume (mL) of e-liquid purchased by participants throughout the entire study were reported.
Measured: up to 90 days
Flavor Preference Questionnaire
Personal flavor questionnaire to determine flavor preference when using ENDS. Absolute favorite flavor of all most commonly used flavors (i.e. Alcohol， Candy， Chocolate， Clove or Spice， Fruit， Menthol or Mint， Other， Tobacco， Unflavored) are reported.
Measured: 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, with the scores ranging of 0 and 100. Data is presented on the percentage of days between sessions participants reported use of product as median and inter-quartile range (IQR). A non-parametric Kruskal-Wallis test followed by Dunn's Multiple Comparisons with Benjamnini-Hochberg adjustment was also performed for each product to assess differences between study groups within a visit, and between visits within a study group.
Measured: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 20223 Oct 2024

First posted21 Jun 2022
Study start12 Jun 2022
Primary completion3 Oct 2024
Study completion3 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05423340
Sponsor's protocol ID: I 2588022
Other IDs: U54CA228110
Acronym: CRoFT
Status last verified: Jun 2026
First submitted: 3 Jun 2022
Last updated: 4 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
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§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
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Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems

All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05423340
Acronym / sponsor ID: CRoFT / I 2588022
Conditions: Electronic Cigarette Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: University of Rochester, National Institutes of Health (NIH), National Cancer Institute (NCI)
Study start: 12 Jun 2022 (actual)
Primary completion: 3 Oct 2024 (actual)
Study completion: 3 Oct 2024 (actual)
First posted: 21 Jun 2022 (actual)
Results: Posted 4 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Use Own Brand of Flavored Product	Experimental	Other: E-cigarette FlavorParticipants will use their current flavor of e cigarettes for 90 days
Use Provided Tobacco Flavor	Experimental	Other: E-cigarette FlavorParticipants will use a new assigned flavor for 90 days
Vaping Abstinence - use "Tobacco Free" Nicotine Pouches	Active comparator	Other: Tobacco Free Nicotine PouchParticipants will be asked to stop vaping for 90 days and instead only use the provided 'tobacco free' nicotine pouches.

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E-cigarette FlavorParticipants use an electronic nicotine delivery system with an assigned tobacco-flavored e-liquid	Other	Use Own Brand of Flavored Product, Use Provided Tobacco Flavor
Tobacco Free Nicotine Pouchparticipants will use tobacco free oral nicotine pouches	Other	Vaping Abstinence - use "Tobacco Free" Nicotine Pouches

Primary outcome

Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA
Time frame: Up to around 90 days.
Oxidative stress and inflammation in plasma using ELISA.
Respiratory Tract Inflammation Activity
Time frame: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days
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

3 secondary outcomes

Amount of Recent Flavored Product Use
Time frame: up to 90 days
Flavor Preference Questionnaire
Time frame: Up to 90 days
Frequency of Flavored Product Use
Time frame: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days

Results and safety

Results posted to the registry on 4 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Use Own Brand of Flavored Product	54	47
Use Provided Tobacco Flavor	55	41
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches	54	43

Primary outcome: Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA

Time frame: Up to around 90 days.. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Use Own Brand of Flavored Product n = 47	Use Provided Tobacco Flavor n = 41	Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches n = 43
C-reactive Protein (CRP) Visit 1	7867.6 (3710.1 to 15996)	1348.8 (762.5 to 5551.5)	3151.9 (1431.3 to 11728.7)
C-reactive Protein (CRP) Visit 4	6341.3 (1135.2 to 9081.9)	2051.3 (1289.9 to 4640.3)	3338.8 (0858 to 8005.3)
interleukin-6 (IL-6) Visit 1	0.8 (0.4 to 1)	0.6 (0.5 to 1.2)	0.7 (0.4 to 0.9)
interleukin-6 (IL-6) Visit 4	2 (1.6 to 2.3)	1.8 (1.6 to 2.2)	1.9 (1.5 to 2)
Interluekin-8(IL-8) Visit 1	0.56 (0.33 to 0.65)	0.67 (0.35 to 0.74)	0.64 (0.53 to 0.72)
Interluekin-8(IL-8) Visit 4	0.58 (0.53 to 0.64)	0.59 (0.52 to 0.86)	0.57 (0.5 to 0.74)

Population analysed: A quantitative measure of expression (units:pg/mg) will be produced on Visit 1-beginning of the trial and Visit 4-after 3 months ± 14 days.

Primary outcome: Respiratory Tract Inflammation Activity

Time frame: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days. Median (Inter-Quartile Range). Unit: ppb

Measure	Use Own Brand of Flavored Product n = 47	Use Provided Tobacco Flavor n = 41	Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches n = 43
Visit 1	10.0 (6 to 16)	8 (5 to 12)	11 (8 to 17)
Visit 2	9.5 (7 to 12.2)	9 (5.5 to 12.5)	11.5 (7 to 18.2)
Visit 3	10 (7.8 to 13.2)	8 (6 to 12)	12 (6 to 18.5)
Visit 4	9 (6 to 15.2)	9 (6 to 13)	11.5 (8 to 16.8)

Population analysed: Measurements are taken on Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Use Own Brand of Flavored Product	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Use Provided Tobacco Flavor	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Vaping Abstinence - Use "Tobacco Free" Nicotine Pouches	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Electronic Cigarette Use

Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
RecruitingEarly Phase 1
Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use
Electronic Cigarette Use, Endothelial Dysfunction
Recruiting
Developing an E-Cigarette Cessation Intervention for Hispanic/Latina(o) Youth in Florida: The BReATHE Study
Vaping Teens, Vaping Behaviors
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maciej Goniewicz, PhD principal investigator

Roswell Park

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing E-cigarette Flavor and Tobacco Free Nicotine Pouch in people with Electronic Cigarette Use, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA (time frame: Up to around 90 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05423340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.