Evaluating Selected Constituents in the Exhaled Breath Samples

Tobacco Use Clinical Trial

Official title: An Open-Label, Multi-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)

Status Completed

Clinical Trial Summary

An Open-Label, Multi-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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cigarette Use, Electronic
• Electronic Cigarette Use
• Tobacco Smoking
• Tobacco Use

• NCT number: NCT04143256
• Study type: Interventional
• Source: Juul Labs, Inc.
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Completion date: December 13, 2019