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NCT04192032 · ClinicalTrials.gov registry record · NA
Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures
A NA study, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT04192032: Completed NA study, sponsored by Florida International University.
NCT04192032 is a NA study that has completed, run by Florida International University. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04192032, a NA study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study will recruit 80 young (18-24) JUUL users, in a 2x2 cross over lab study where in one condition they will use their JUUL preferred flavor and the other JUUL standard tobacco flavor. Our aims are to; Aim 1: Compare satisfaction, withdrawal suppression, and harm perception between tobacco-flavored and preferred flavor JUUL. This analysis will reveal the extent to which preferred flavor contributes to smoking satisfaction, withdrawal and craving suppression, and harm perception, compared to the standard tobacco flavor. Aim 2: Compare puff topography and plasma nicotine levels between tobacco-flavored and preferred flavor JUUL. This analysis will examine the extent to which preferred flavor contributes to puffing behavior and toxicant exposure compared to the standard tobacco flavor. Aim 3: Compare exhaled breath condensate (EBC) between tobacco-flavored and preferred flavor JUUL. This analysis will be the first to examine exposure to toxic aldehydes (formaldehyde, acetaldehyde, acrolein, benzaldehyde, and propionaldehyde) produced when using preferred flavor compared to the standard tobacco flavor. Utilizing powerful clinical lab methods, this study will provide a broad testing of the effect of flavor manipulation on college-aged JUUL users, and provide experimental evidence about the potential of flavor-limitation policies on young ENDS users in the US.
Primary Outcome
Change in plasma nicotine level
Interventions
- OTHER Preferred Juul pod flavor (5% nicotine)
- OTHER Classic Tobacco Juul pod flavor (5% nicotine)
- OTHER Preferred flavor with HWL
- OTHER Preferred flavor, 3% nicotine
- OTHER Preferred flavor, 0% nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2020-03-15 |
| Phase | NA |
What the finished NCT04192032 record still lists
NCT04192032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Preferred Juul pod flavor (5% nicotine) is the first listed.
NCT04192032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04192032 about?
NCT04192032 is a clinical study titled "Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures". Recently, Maziak established a clinical lab at FIU to test the potential of waterpipe tobacco flavor regulation by the FDA. Given the importance of flavors on adolescent ENDS uptake and use, this lab is equipped to study the impact of flavor manipulations among adolescent ENDS users. In this study w...
What is the current status of trial NCT04192032?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2018-11-15. Estimated completion is 2020-03-15.
What interventions are being tested in trial NCT04192032?
The interventions under investigation include: Preferred Juul pod flavor (5% nicotine) (OTHER), Classic Tobacco Juul pod flavor (5% nicotine) (OTHER), Preferred flavor with HWL (OTHER), Preferred flavor, 3% nicotine (OTHER), Preferred flavor, 0% nicotine (OTHER).
Who is sponsoring clinical trial NCT04192032?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04192032's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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