Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures
Completed · Not applicable
Conditions studied: Electronic Cigarette Use
In brief
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.
Key facts
- Study ID
- NCT04192032
- Run by
- Florida International University
- People needed
- 41
- Starts
- 2018-11-15
- Expected to finish
- 2020-03-15
- Last updated by the study team
- 2021-01-26
Who can join
Age: 18 and older, up to 24. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Generally healthy individuals (determined by physical examination).
- Age of 18-24 years.
- Is willing to provide informed consent.
- Is willing to attend the lab as required by the study protocol.
- Regular Juul smokers (at least weekly for the past 3 months).
- Have abstained from Juul use for 12 hours prior to each session.
You may not qualify if…
- Report smoking cigarettes regularly (> 5 cigarettes/month in the past year).
- Report regular use of any other tobacco/nicotine product (e.g., e-cig, pipes, cigars) in the past year.
- Women who are breast-feeding or test positive for pregnancy (by urinalysis at screening).
- Individuals with self-reported history of chronic disease or psychiatric conditions.
- Individuals with history of or active cardiovascular disease, low or high blood pressure, seizures, and regular use of prescription medications (other than vitamins or birth control).
- Individuals that report THC (marijuana) smoking/vaping.
- Individuals that report the use of non-commercial (i.e., street) e-cigarette liquid or products
- Individuals that report current EVALI-related symptoms (i.e., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, diarrhea, fever, chills, or weight loss)
Where it is running
- Florida International University — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.