Tobacco-Related CarcinomaNCT05876091

Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

A study testing Vaping, Biospecimen Collection and Questionnaire Administration in people with Tobacco-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco-Related Carcinoma
What is being tested?: Vaping, Biospecimen Collection and Questionnaire Administration
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2023to 29 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

Current daily vapers of products containing nicotine
No daily concurrent use of other tobacco products
Self-reported general good health
Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
Ability to speak, read, and write in English
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

Who cannot join

Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
Self-reported taste or smell deficits
Pregnant or nursing female participants
Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
Unwilling to use open system vaping device in laboratory setting
Positive diagnosis of human coronavirus 2019 infection (COVID-19) within 10 days prior to start of study intervention
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263

Other trials in United States

About this study

This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.

Read the detailed description

PRIMARY OBJECTIVE:

Examine the influence of tobacco flavoring composition on vaping topography.
Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

SECONDARY OBJECTIVE:

Examine the influence of tobacco flavoring composition on vaping topography.
Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

OUTLINE:

The order of directed and ad libitum bouts are randomized within participants at each session.

SESSION 1: Participants puff their own brand liquid on study.

SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.

SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.

Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Conditions: Tobacco-Related Carcinoma
Being tested: Vaping, Biospecimen Collection, Questionnaire Administration

What participants receive

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

VapingOther
Also called Vape, Vaping
Undergo vape puffing regimen
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of saliva samples and oral cell samples
Questionnaire AdministrationOther
Administer Quesitonnaire

Study groups in NCT05876091
Study group	Role	What they receive
Vaping -	Experimental	Description The order of directed and ad libitum bouts are randomized within participants at each session. SESSION 1: Participants puff their own brand liquid on study. SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study. Receives: Other: Vaping; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

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

Puff Topography: Puff Count
Measure of vaping topography counting total number of puffs.
Measured: Single Session, Approximately 2 hours in duration
Puff Topography: Puff Duration (in Seconds)
Measure of vaping topography counting duration of puffs in seconds.
Measured: Single Session, Approximately 2 hours in duration
Puff Topography: Inter Puff Interval (IPI)
Measure of vaping topography counting the interval between puffs in seconds.
Measured: Single Session, Approximately 2 hours in duration
Puff Topography: Puff Volume
Measure of vaping topography measuring the volume per puff in ml.
Measured: Single Session, Approximately 2 hours in duration
Puff Topography: Flow Rate
Measure of vaping topography measuring the rate of flow per puff in milliliters per second.
Measured: Single Session, Approximately 2 hours in duration

Secondary outcomes (1)

Subjective Questionnaires of Product Evaluation
Will be assessed by Duke Sensory Scale
Measured: Single Session, Approximately 2 hours in duration

Timeline

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

30 Aug 202329 Oct 2024

First posted25 May 2023
Study start30 Aug 2023
Primary completion8 Oct 2024
Study completion29 Oct 2024

Why it stopped: End of grant

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 Tobacco-Related CarcinomaStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05876091
Sponsor's protocol ID: I 3234822
Other IDs: U54CA228110
Status last verified: Dec 2025
First submitted: 16 May 2023
Last updated: 22 Dec 2025
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

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All Tobacco-Related Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
ClinicalTrials.gov ID: NCT05876091
Acronym / sponsor ID: I 3234822
Conditions: Tobacco-Related Carcinoma
Study type: Interventional
Recruitment status: TerminatedReason stopped: End of grant
Enrolment: 21 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 30 Aug 2023 (actual)
Primary completion: 8 Oct 2024 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 25 May 2023 (actual)
Results: Posted 22 Dec 2025

Clinical summary

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

Detailed description

PRIMARY OBJECTIVE:

Examine the influence of tobacco flavoring composition on vaping topography.
Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

SECONDARY OBJECTIVE:

Examine the influence of tobacco flavoring composition on vaping topography.
Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

OUTLINE:

The order of directed and ad libitum bouts are randomized within participants at each session.

SESSION 1: Participants puff their own brand liquid on study.

SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.

SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.

Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vaping -	Experimental	Other: Vaping, Procedure: Biospecimen Collection, Other: Questionnaire AdministrationDescription The order of directed and ad libitum bouts are randomized within participants at each session. SESSION 1: Participants puff their own brand liquid on study. SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study. SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study. Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Who may qualify

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

Key inclusion criteria (6 listed)

Current daily vapers of products containing nicotine
No daily concurrent use of other tobacco products
Self-reported general good health
Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
Ability to speak, read, and write in English

Key exclusion criteria (8 listed)

Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
Self-reported taste or smell deficits
Pregnant or nursing female participants
Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
Unwilling to use open system vaping device in laboratory setting

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
VapingAlso: Vape, VapingUndergo vape puffing regimen	Other	Vaping -
Biospecimen CollectionAlso: Biological Sample CollectionUndergo collection of saliva samples and oral cell samples	Procedure or surgery	Vaping -
Questionnaire AdministrationAdminister Quesitonnaire	Other	Vaping -

Primary outcome

Puff Topography: Puff Count
Time frame: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting total number of puffs.
Puff Topography: Puff Duration (in Seconds)
Time frame: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting duration of puffs in seconds.
Puff Topography: Inter Puff Interval (IPI)
Time frame: Single Session, Approximately 2 hours in duration
Measure of vaping topography counting the interval between puffs in seconds.
Puff Topography: Puff Volume
Time frame: Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the volume per puff in ml.
Puff Topography: Flow Rate
Time frame: Single Session, Approximately 2 hours in duration
Measure of vaping topography measuring the rate of flow per puff in milliliters per second.

1 secondary outcome

Subjective Questionnaires of Product Evaluation
Time frame: Single Session, Approximately 2 hours in duration

Results and safety

Results posted to the registry on 22 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study Population	18	18

Primary outcome: Puff Topography: Puff Count

Time frame: Single Session, Approximately 2 hours in duration. Mean (Standard Error). Unit: Number of Puffs

Measure	Session 1: Own Brand Puff Count Ad Lib n = 18	Session 1: Own Brand Puff Count Directed n = 18	Sessions 2-5: Cowboy Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: Cowboy Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Count Directed n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Count Ad Lib n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Count Directed n = 17	Session 6-7: Tobacco Derived Liquid Puff Count Ad Lib n = 17	Session 6-7: Tobacco Derived Liquid Puff Count Directed n = 17
Value	13.9 (2.3)	6.4 (0.8)	13.2 (2.2)	5.8 (0.8)	15.4 (3.1)	5.9 (0.9)	13.2 (2.2)	5.8 (0.9)	13.0 (2.2)	6.3 (1.2)	14.3 (2.4)	7.1 (0.9)	13.4 (1.8)	7.0 (0.9)

Primary outcome: Puff Topography: Puff Duration (in Seconds)

Time frame: Single Session, Approximately 2 hours in duration. Mean (Standard Error). Unit: Mean Duration of Puffs (in seconds)

Measure	Session 1: Own Brand Puff Duration Ad Lib n = 18	Session 1: Own Brand Puff Duration Directed n = 18	Sessions 2-5: Cowboy Vaping Liquid Puff Duration Ad Lib n = 17	Sessions 2-5: Cowboy Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Count Directed n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Count Ad Lib n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Count Directed n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Duration Ad Lib n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Duration Directed n = 17	Session 6-7: Tobacco Derived Liquid Puff Duration Ad Lib n = 17	Session 6-7: Tobacco Derived Liquid Puff Duration Directed n = 17
Value	2.2 (0.3)	3.5 (0.3)	2.3 (0.3)	3.1 (0.3)	2.5 (0.4)	3.0 (0.3)	2.3 (0.3)	3.2 (0.3)	2.1 (0.2)	2.9 (0.3)	2.4 (0.4)	3.0 (0.3)	2.2 (0.3)	2.9 (0.3)

Primary outcome: Puff Topography: Inter Puff Interval (IPI)

Time frame: Single Session, Approximately 2 hours in duration. Mean (Standard Error). Unit: Mean number of seconds between puffs

Measure	Session 1: Own Brand Inter Puff Interval Ad Lib n = 18	Session 1: Own Brand Inter Puff Interval Directed n = 18	Sessions 2-5: Cowboy Vaping Inter Puff Interval Ad Lib n = 17	Sessions 2-5: Cowboy Vaping Liquid Inter Puff Interval Directed n = 17	Sessions 2-5: RY4 Double Vaping Liquid Inter Puff Interval Ad Lib n = 17	Sessions 2-5: RY4 Double Vaping Liquid Inter Puff Interval Directed n = 17	Sessions 2-5: Unflavored Vaping Liquid Inter Puff Interval Ad Lib n = 17	Sessions 2-5: Unflavored Vaping Liquid Inter Puff Interval Directed n = 17	Sessions 2-5: Red Oak Vaping Liquid Inter Puff Interval Ad Lib n = 17	Sessions 2-5: Red Oak Vaping Liquid Inter Puff Interval Directed n = 17	Session 6-7: Synthetic Nicotine Liquid Inter Puff Interval Ad Lib n = 17	Session 6-7: Synthetic Nicotine Liquid Inter Puff Interval Directed n = 17	Session 6-7: Tobacco Derived Liquid Inter Puff Interval Ad Lib n = 17	Session 6-7: Tobacco Derived Liquid Inter Puff Interval Directed n = 17
Value	82.2 (14.0)	55.2 (6.1)	61.4 (10.7)	58.0 (4.2)	71.6 (10.3)	54.2 (3.6)	71.6 (8.7)	56.7 (4.0)	55.1 (8.1)	60.6 (5.4)	84.6 (12.0)	59.3 (4.1)	78.7 (11.0)	56.6 (3.5)

Primary outcome: Puff Topography: Puff Volume

Time frame: Single Session, Approximately 2 hours in duration. Mean (Standard Error). Unit: Volume per puff (ml)

Measure	Session 1: Own Brand Puff Volume Ad Lib n = 18	Session 1: Own Brand Puff Volume Directed n = 18	Sessions 2-5: Cowboy Vaping Liquid Puff Volume Ad Lib n = 17	Sessions 2-5: Cowboy Vaping Liquid Puff Volume Directed n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Volume Ad Lib n = 17	Sessions 2-5: RY4 Double Vaping Liquid Puff Volume Directed n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Volume Ad Lib n = 17	Sessions 2-5: Unflavored Vaping Liquid Puff Volume Directed n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Volume Ad Lib n = 17	Sessions 2-5: Red Oak Vaping Liquid Puff Volume Directed n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Volume Ad Lib n = 17	Session 6-7: Synthetic Nicotine Liquid Puff Volume Directed n = 17	Session 6-7: Tobacco Derived Liquid Puff Volume Ad Lib n = 17	Session 6-7: Tobacco Derived Liquid Puff Volume Directed n = 17
Value	63.5 (13.2)	102.2 (16.1)	66.2 (11.4)	81.4 (14.7)	83.6 (17.2)	103.1 (18.6)	63.9 (8.1)	88.3 (13.5)	57.5 (6.5)	74.9 (10.61)	86.7 (14.9)	96.3 (13.5)	76.9 (9.8)	92.0 (15.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Session 1: Own Brand Topography Ad Lib	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Session 1: Own Brand Topography Directed	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Sessions 2-5: Cowboy Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: Cowboy Liquid Vaping Liquid Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: RY4 Vaping Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: RY4 Vaping Liquid Topography Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: Red Oak Vaping Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: Red Oak Vaping Liquid Topography Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 2-5: Unflavored Vaping Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Unflavored Vaping Liquid Vaping Topography Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 6-7: Synthetic Nicotine Vaping Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 6-7: Synthetic Vaping Liquid Topography Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 6-7: Tobacco Derived Vaping Liquid Topography Ad Lib	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Sessions 6-7: Tobacco Derived Vaping Liquid Topography Directed	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Richard O'Connor 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 Vaping, Biospecimen Collection and Questionnaire Administration in people with Tobacco-Related Carcinoma, 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Dec 2025. 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 22 Dec 2025). 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?

Puff Topography: Puff Count (time frame: Single Session, Approximately 2 hours in duration). The study lists 5 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 NCT05876091.

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 22 Dec 2025.