Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth (NCT05458895) | Clinical Trial Compass
CompletedNot Applicable
Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
United States88 participantsStarted 2021-12-02
Plain-language summary
This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.
Who can participate
Age range
21 Years – 25 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:
* A current exclusive e-cigarette user (\>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
* 21-25 years old
* Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
* Willing to complete five, 6 hour lab visits
* Able to read and speak English
* Willing to provide informed consent
Exclusion Criteria:
* Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
* Use of other tobacco products \> 5 days in the past month
* Current marijuana use \> 5 times per month
* Currently engaging in a vaping cessation attempt
* Ohio State University (OSU) verifies study project 2 current membership/past participation
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
Plasma Nicotine Concentration
Timeframe: 0, 5, 10, 35 min.
2
Puff Count
Timeframe: 30 minutes
3
Average Puff Duration
Timeframe: 30 minutes
4
Average Puff Volume
Timeframe: 30 minutes
5
Lung Function Assessment
Timeframe: Baseline and 35 minutes
6
Airway Inflammation (NIOX VERO)
Timeframe: 35 minutes
Trial details
NCT IDNCT05458895
SponsorOhio State University Comprehensive Cancer Center