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

NCT04192032 | Completed

• 1 other identifier: 107308
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Plasma nicotine

  Change in plasma nicotine level

  During five participant visits. Blood will be taken 2 times in each JUUL use session: before and after an approximately 60-min ad lib use period

Secondary Outcomes (7)

• Puff topography

  During participants' five study visits. Puffing behavior is continuously measured during each Juul use session (an approximately 60-min ad lib use period)

• Minnesota Nicotine Withdrawal Scale

  During participants' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-min ad lib use period.]

• Tiffany-Drobes Questionnaire of Smoking Urges

  During participants' five study visits. Questionnaire will be administered 2 times in each Juul use session: before and after an approximately 60-min ad lib use period.]

• Carbon monoxide levels

  During participants' five study visits. Carbon monoxide levels will be measured 2 times in each Juul use session: before and after an approximately 60-min ad lib use period

• Harm perception

  During participants' five study visits. Questionnaire will be administered after each of the 2 Juul use sessions. Each session is approximately 60-min ad lib use period.]

Other Outcomes (2)

• Heart rate

  During participants' five study visits. Heat rate will be measured from baseline continuously throughout each approximately 60-min session.

• Blood pressure

  During participants' five study visits. Blood pressure will be measured from baseline continuously throughout each approximately 60-min session

Study Arms (5)

Preferred flavor (5% nicotine)

EXPERIMENTAL

Preferred flavor Juul pod (5% nicotine)

Other: Preferred Juul pod flavor (5% nicotine)

Classic Tobacco Flavor

ACTIVE COMPARATOR

Control flavor (5% Classic Tobacco flavor Juul pod)

Other: Classic Tobacco Juul pod flavor (5% nicotine)

Preferred flavor with HWL

EXPERIMENTAL

Preferred flavored Juul pod (5% nicotine) with HWL

Other: Preferred flavor with HWL

Preferred flavor (3% nicotine)

EXPERIMENTAL

Preferred flavored Juul pod (3% nicotine)

Other: Preferred flavor, 3% nicotine

Preferred flavor (0% nicotine)

EXPERIMENTAL

Preferred flavored Juul pod (0% nicotine)

Other: Preferred flavor, 0% nicotine

Interventions

Preferred Juul pod flavor (5% nicotine) OTHER

Preferred Juul pod flavor (5% nicotine)

Preferred flavor (5% nicotine)

Classic Tobacco Juul pod flavor (5% nicotine) OTHER

Classic Tobacco Juul pod flavor (5% nicotine)

Classic Tobacco Flavor

Preferred flavor with HWL OTHER

Preferred flavor (5% nicotine) with HWL

Preferred flavor with HWL

Preferred flavor, 3% nicotine OTHER

Preferred flavor, 3% nicotine

Preferred flavor (3% nicotine)

Preferred flavor, 0% nicotine OTHER

Preferred flavor, 0% nicotine

Preferred flavor (0% nicotine)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wasim Maziak, MD, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this study, we will recruit 80 young (18-24) JUUL users. Each participant will undergo 3 JUUL smoking sessions: 1) one where they will be vaping their preferred flavor; 2) one where they will be vaping the standard classic tobacco flavor; 3) a third one in which they will be vaping their preferred flavor in a JUUL Ecigarette (JEC) device that has a health warning label (HWL) attached to it. In addition, 10 participants will be invited to come back for two additional sessions: one in which they will be vaping their preferred flavor pod with a 3% nicotine concentration, and one in which they will use their preferred flavor pod with 0% nicotine concentration. Measurement of JUUL satisfaction, dependence, harm perception, and exposure to nicotine and toxicants will be conducted in all 5 sessions.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 10, 2019
• Study Start: November 15, 2018
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)