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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 is a NA study that has completed, run by Florida International University. The registered enrollment target is 41 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04192032
The ClinicalTrials.gov registry entry for NCT04192032 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Preferred Juul pod flavor (5% nicotine) is the first listed.
NCT04192032 reports 0 study locations.
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.
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