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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
279
JUUL 5%, ENDS for 6-days in confinement
JUUL 3%, ENDS for 6-days in confinement
JUUL 5%, ENDS for 6-days in confinement
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
St. Louis Clinical Trials
St Louis, Missouri, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Primary biomarkers of tobacco exposure measured in urine
Excretion of urine total NNAL, 3-HPMA, MHBMA, and S-PMA will be assessed at baseline and following a 6-day interventional period.
Time frame: 6 days
Primary biomarker of tobacco exposure measured in blood
Exposure to carbon monoxide will be assessed through measurement of blood COHb at baseline and following a 6-day interventional period.
Time frame: 6 days
Secondary biomarkers of tobacco exposure measured in urine
Excretion of total NNN, total 1-OHP, O-toluidine, 2-NA, 4-ABP, and urine mutagenic activity will be assessed at baseline and following a 6-day interventional period.
Time frame: 6 days
Subjective product assessments as measured by the Modified Product Evaluation Scale
Subjective product assessments as measured by responses to the Modified Product Evaluation Scale will be made at baseline and during the interventional period.
Time frame: 6 days
Product liking as measured by the Product-Liking Questionnaire visual analog scale
The degree to which subjects like the product will be assessed using the Product-Liking Questionnaire at baseline and during the interventional period.
Time frame: 6 days
Urge to smoke as measured by the Urge to Smoke a Cigarette Questionnaire visual analog scale
Urge to smoke as measured by responses to the Urge to Smoke a Cigarette Questionnaire will be assessed at baseline and during the interventional period.
Time frame: 6 days
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JUUL 3%, ENDS for 6-days in confinement
JUUL 5%, ENDS for 6-days in confinement
JUUL 3%, ENDS for 6-days in confinement
JUUL 5%, ENDS for 6-days in confinement
JUUL 3%, ENDS for 6-days in confinement
Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement
No smoking for 6-days in confinement.
Continue smoking UB for 6-days in confinement.
Endeavor Clinical Trials
San Antonio, Texas, United States
Likelihood of future product use as measured by the Future Intent to Use the Product Questionnaire visual analog scale
Likelihood of future product use as measured by responses to the Future Intent to Use the Product Questionnaire will be made at baseline and during the interventional period.
Time frame: 6 days
Daily JUUL product consumption
Daily consumption of the JUUL products as measured by the change in pod weight after use during the interventional period will be reported.
Time frame: 6 days
Daily combustible cigarette consumption
Daily consumption of combustible cigarettes as measured by the number of cigarettes smoked per day at baseline and during the interventional period will be reported.
Time frame: 6 days
Incidence of adverse events
Safety and tolerability will be assessed by monitoring the incidence of product-use emergent adverse events.
Time frame: 6 days