Clinical Trial

Effect of JUUL Flavor on Users' Experiences and Exposures

Study Description

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 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Preferred Juul pod flavor (5% nicotine)

Preferred Juul pod flavor (5% nicotine)

Classic Tobacco Juul pod flavor (5% nicotine)

Classic Tobacco Juul pod flavor (5% nicotine)

Preferred flavor with HWL

Preferred flavor (5% nicotine) with HWL

Preferred flavor, 3% nicotine

Preferred flavor, 3% nicotine

Preferred flavor, 0% nicotine

Preferred flavor, 0% nicotine

Additional Information

Official Study Title

Assessing the Effect of Flavor on College-Aged JUUL ENDS Users' Experiences and Exposures

Clinical Trial ID

NCT04192032

ParticipAid ID

dyPKVb