Topics

Evaluating Selected Constituents in the Exhaled Breath Samples

2019-11-03 15:10:58 | BioPortfolio

Summary

An Open-Label, Single-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)

Description

The objective of this study is to evaluate the baseline-adjusted level of selected constituents in the exhaled breath sample (EBS) between the two JUUL NSPS products (5% vs 3% nicotine by weight) for Virginia Tobacco, Mint, Mango and Menthol flavor and to compare the change in absolute level of selected constituents in EBS before and after the use of JUUL NSPS (5% and 3% nicotine by weight; Virginia Tobacco, Mint, Mango, Menthol flavors) to the change in absolute level of selected constituents before and after the use of menthol and non-menthol cigarettes.

Subjects will be screened for participation in the trial up to 28 days before Day 1. Along with screening procedures, all subjects will receive training on EBS collection procedures. All subjects will be further trained on the CPS using a training video and site instructions. Trained subjects will have the opportunity to try the JUUL NSPS.

Eligible subjects will be scheduled for a Day 1 clinic visit. Within 24 to 48 hours prior to Check-in, the clinic staff will provide a courtesy phone call to subjects to remind them to abstain from the use of alcohol, any nicotine-containing products and mint/mentholated products for at least 12 hours prior and xanthines/caffeine for at least 24 hours prior to screening and Day 1.

Following completion of the check-in events, including re-instruction on the EBS sample collection technique and CPS instructions, subjects will participate in the exhaled breath collection test sessions.

Groups I - IV will complete two periods of baseline and test sample collections with a 3-hour break in between each period. Each period will consist of two baseline samples (the first for analysis of nicotine, propylene glycol and glycerin and the second for analysis of acetaldehyde, acrolein, benzoic acid, formaldehyde, and menthol), followed by product use, and then two test samples (similar to baseline). Exhaled CO will be measured before the first baseline sample, after the second baseline sample, before the first test sample and after the second test sample. Pods used during the test sessions will be weighed before and after use.

Groups V and VI will complete only one period of baseline and test sample collections, consisting of two baseline sample collections and two test sample collections similar to that noted above.

A follow-up phone call with subjects will be made the day after Check-out (or early withdrawal). Provided there are no adverse events which require further attention, the subject's participation in the trial will be complete.

Study Design

Conditions

Electronic Cigarette Use

Intervention

JUUL ENDS 5% Virginia Tobacco, JUUL 3% Virginia Tobacco ENDS, JUUL 5% Mint ENDS, JUUL 3% Mint ENDS, JUUL 5% Menthol ENDS, JUUL 3% Menthol ENDS, JUUL 5% Mango ENDS, JUUL 3% Mango ENDS, US Cigarette, Non-menthol - Marlboro Gold King Size, US Cigarette, Ment

Location

Frontage Clinical Services
Secaucus
New Jersey
United States
07094

Status

Recruiting

Source

Juul Labs, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-03T15:10:58-0500

Clinical Trials [1031 Associated Clinical Trials listed on BioPortfolio]

Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers

A randomized, open label, 2-group, 4-period cross-over study in adult closed system ENDS consumers designed to evaluate puff topography parameters with use of JUUL ENDS products (Virginia ...

Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% ENDs in Adult Smokers

The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to combustible cigarette use. This study aims to find out how much nicotine is in the blood and ur...

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Ele...

United States Pre-Market Tobacco Application Pharmacokinetics

A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combust...

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

PubMed Articles [995 Associated PubMed Articles listed on BioPortfolio]

I wake up and hit the JUUL: Analyzing Twitter for JUUL nicotine effects and dependence.

JUUL-a novel electronic nicotine delivery system (ENDS)-comprises most of the ENDS market share. Additionally, JUUL has a high nicotine content and utilizes a patented nicotine salt formulation aimed ...

JUUL in school: JUUL electronic cigarette use patterns, reasons for use, and social normative perceptions among college student ever users.

JUUL electronic cigarettes have surged in popularity since their emergence on the market in 2015. JUUL is slim and simple in design and is capable of delivering cigarette-like levels of nicotine. Howe...

An analysis of e-cigarette marketing in New Zealand tobacco retail outlets prior to legislative change.

In 2017, the New Zealand (NZ) Government announced its intention to liberalise the sale and promotion of electronic nicotine delivery systems (ENDS), including permitting any outlet to sell ENDS. This...

Flavored ENDS Use among Adults Who Have Used Cigarettes and ENDS, 2016-2017.

In this study, we assessed differences in type, number, and perceptions of ENDS flavors used at initiation and currently among 4 smoking and ENDS use profiles of US adults with a history of smoking an...

Sociodemographic Correlates of Electronic Nicotine Delivery Systems (ENDS) Use in the United States, 2016-2017.

To investigate use of electronic nicotine delivery systems (ENDS) among priority populations. Using 2016 through 2017 US nationally representative surveys (n = 11 688), we examined ENDS use by ...

Medical and Biotech [MESH] Definitions

A state bounded on the north by Pennsylvania, on the east by Delaware and the Atlantic Ocean, on the south by Virginia and West Virginia, and on the west by West Virginia.

Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.

The aggregate business enterprise of agriculture, manufacture, and distribution related to tobacco and tobacco-derived products.

State bounded on the north by Maryland and West Virginia, on the east by the Atlantic Ocean, the Chesapeake Bay and Maryland, and on the south by North Carolina and Tennessee, and on the west by Kentucky and West Virginia.

Use of TOBACCO (Nicotiana tabacum L) and TOBACCO PRODUCTS.

More From BioPortfolio on "Evaluating Selected Constituents in the Exhaled Breath Samples"

Quick Search

Relevant Topic

Respiratory
Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...


Searches Linking to this Trial