Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography (NCT05876091) | Clinical Trial Compass
TerminatedNot Applicable
Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Stopped: End of grant
United States21 participantsStarted 2023-08-30
Plain-language summary
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.
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether its findings about vaping behavior and tobacco-related cancer risk are still relevant to my situation?
2Since this study was measuring things like how often and how deeply people puff on e-cigarettes, what does that kind of research actually tell us about my risk for tobacco-related carcinoma, and should it change anything about my current care plan?
3Given that this trial has already been terminated and isn't enrolling anyone, are there other active studies on vaping and tobacco-related cancer that might be worth considering instead?
4This was listed as a non-phase study focused on observation of vaping patterns rather than a treatment — does that mean it wouldn't have offered me any direct medical benefit, and is there a treatment-focused trial that might be more appropriate for where I am in my diagnosis?
5Is there anything from research like this — looking at how vaping habits relate to tobacco-related carcinoma — that you think I should factor into decisions I'm already making about my treatment or lifestyle?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Puff Topography: Puff Count
Timeframe: Single Session, Approximately 2 hours in duration
2
Puff Topography: Puff Duration (in Seconds)
Timeframe: Single Session, Approximately 2 hours in duration
3
Puff Topography: Inter Puff Interval (IPI)
Timeframe: Single Session, Approximately 2 hours in duration
4
Puff Topography: Puff Volume
Timeframe: Single Session, Approximately 2 hours in duration
5
Puff Topography: Flow Rate
Timeframe: Single Session, Approximately 2 hours in duration