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

2019-10-03 07:54:45 | BioPortfolio

Summary

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 Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

Description

Previous studies and data reported in the literature support that Electronic Nicotine Delivery Systems (ENDS) have less toxicant exposure. This study will serve as a clinical evaluation of exclusive-use of selected JUUL ENDS in 2 different nicotine concentrations (5%, 3%), with the purpose of gaining data to support the hypothesis that exclusive-use of JUUL ENDS over the course of 6 days will result in a significant reduction in toxicant exposure compared to combustible cigarettes.

This will be a randomized, open label, parallel group study in adult smokers to be conducted at up to 5 sites in the United States. Changes in Biomarkers of Exposure (BoEs) from baseline when using four JUUL ENDS with 2 different nicotine concentrations (5%, 3%) relative to Usual Brand (UB) of combustible cigarettes and a study group abstaining from any tobacco/nicotine product use will be assessed in this study. JUUL ENDS will be used either exclusively or partially (dual-use), with subjects in the dual-use group using both JUUL 5% ENDS (choice of Virginia Tobacco (VT), Mint, Menthol or Mango flavors) and UB of combustible cigarettes.

Study Design

Conditions

Electronic Cigarette Use

Intervention

Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS, Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS, Switch from UB of Combustible Cigarette to JU

Location

Woodland International Research Group
Little Rock
Arkansas
United States
72211

Status

Enrolling by invitation

Source

Juul Labs, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-03T07:54:45-0400

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