Testing the Effect of ENDS Flavors on Neurotransmission (NCT05836051) | Clinical Trial Compass
CompletedNot Applicable
Testing the Effect of ENDS Flavors on Neurotransmission
United States36 participantsStarted 2023-06-01
Plain-language summary
The overarching goal of this translational proposal is to determine if neuroactive flavor chemicals can enhance the addiction potential of electronic nicotine delivery systems (ENDS) by altering brain function and behavior.
Who can participate
Age range
21 Years – 60 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
. 21 to 60 years old
. Regular users of inhaled tobacco products (≥5 days out of the last 28)
. Not planning to quit tobacco use within next month
. Able to read and write in English
Exclusion criteria
. Major neurological conditions or brain trauma
. Current substance use impairing participation
. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
. Current use of smoking cessation medication (e.g., varenicline, patch)
. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
. Unable to use study provided ENDS ad-libitum for at least 3 hours per day
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Brain Reward Reactivity
Timeframe: Pre to post-intervention (approximately 10 days)
2
Absolute Reinforcement
Timeframe: Pre to post-intervention (approximately 10 days)