Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures

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.

Conditions

• Electronic Cigarette Use

Interventions

OTHER

Preferred Juul pod flavor (5% nicotine)

Preferred Juul pod flavor (5% nicotine)

OTHER

Classic Tobacco Juul pod flavor (5% nicotine)

Classic Tobacco Juul pod flavor (5% nicotine)

OTHER

Preferred flavor with HWL

Preferred flavor (5% nicotine) with HWL

OTHER

Preferred flavor, 3% nicotine

Preferred flavor, 3% nicotine

OTHER

Preferred flavor, 0% nicotine

Preferred flavor, 0% nicotine

Sponsors & Collaborators

• Florida International University

  lead OTHER

Principal Investigators

• Wasim Maziak, MD, PhD · Florida International University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-15

Primary Completion

2020-03-15

Completion

2020-03-15

Countries

• United States

Study Locations