Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Recruiting NCT06033599 - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Phase 3
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Completed NCT01311830 - Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons N/A
Completed NCT04566198 - Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Completed NCT04107779 - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS N/A
Completed NCT05092919 - The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults Early Phase 1
Terminated NCT05274217 - Journey of Transformation Curriculum for Native American Adolescents N/A
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Recruiting NCT05380765 - Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents N/A
Completed NCT03235713 - EMA for Tobacco Control Policy Research
Withdrawn NCT03352635 - Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core N/A
Completed NCT03151421 - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home N/A
Completed NCT03446170 - Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers N/A
Completed NCT04104152 - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting N/A
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT04632030 - Shrinking the Size of the Tobacco Power Wall N/A