Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Virginia Tobacco and 3% Virginia Tobacco

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mint and 3% Mint

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Menthol and 3% Menthol

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mango and 3% Mango

Subjects with cigarette user history will be assigned to use US Cigarette, Non-Menthol Flavor (Marlboro Gold King Size)

Subjects with cigarette user history will be assigned to use US Cigarette, Menthol Flavor (Newport King Size)

Electronic Cigarette Use

Cigarette Use, Electronic

Tobacco Use

Tobacco Smoking

JUUL ENDS Virginia Tobacco 5% nicotine strength

JUUL ENDS 5% Virginia Tobacco

JUUL ENDS Virginia Tobacco 3% nicotine strength

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, Menthol - Newport King Size

Frontage Clinical Services

Rose Research Center

Evaluating Selected Constituents in the Exhaled Breath Samples

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)

The absolute change from baseline level of nicotine for each subject.

The absolute change from baseline level of propylene glycol for each subject.

The absolute change from baseline level of vegetable glycerin for each subject.

The absolute change from baseline level of acetaldehyde for each subject.

The absolute change from baseline level of acrolein for each subject.

The absolute change from baseline level of benzoic acid for each subject.

The absolute change from baseline level of formaldehyde for each subject.

The absolute change from baseline level of menthol for each subject.

The absolute change from baseline level of carbon monoxide for each subject.

Compare the change between baseline and post-baseline levels of nicotine for each subject.

Compare the change between baseline and post-baseline levels of propylene glycol for each subject.

Compare the change between baseline and post-baseline levels of vegetable glycerin for each subject.

Compare the change between baseline and post-baseline levels of acetaldehyde for each subject.

Compare the change between baseline and post-baseline levels of acrolein for each subject.

Compare the change between baseline and post-baseline levels of benzoic acid for each subject.

Compare the change between baseline and post-baseline levels of formaldehyde for each subject.

Compare the change between baseline and post-baseline levels of menthol for each subject.

Compare the change between baseline and post-baseline levels of carbon monoxide for each subject.

Change in the weight of JUUL pods before and after the usage.

There is no plan to share IPD to other researchers.

Juul Labs, Inc.

Four crossover groups and two single arm groups

Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Virginia Tobacco ENDS, JUUL 3% Virginia Tobacco ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.

Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Mint ENDS, JUUL 3% Mint ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.

Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Menthol ENDS, JUUL 3% Menthol ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.

Subjects will use 5 products according to a randomized crossover assignment: JUUL 5% Mango ENDS, JUUL 3% Mango ENDS, Subject's UB combustible cigarette, Comparator e-cigarette, Nicorette White Ice Mint 4 mg nicotine polacrilex gum.

JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum

Altasciences Clinical Kansas, Inc.

Central Kentucky Research Associates

Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

A Randomized, Open-Label, Cross-Over Study to Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems With Multiple Flavors and Nicotine Concentrations, Usual Brand of Combustible Cigarettes, a Comparator E-Cigarette and Nicotine Gum in Adult Smokers

Baseline-adjusted maximum plasma nicotine concentration [Cmax]

Maximum response to the Product-Liking Questionnaire (visual analog scale, range of "not at all" to "a great deal")

Time of the maximum post-baseline nicotine concentration

Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 30 minutes

Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 60 minutes

Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time 0 to 120 minutes

Maximum response to the Nicotine Withdrawal Questionnaire (visual analog scale, range "not at all" to "extremely")

Maximum response to the Product Direct Effects Questionnaire (visual analog scale, range "not at all" to "extremely")

Subjective product assessments as measured by responses to the Modified Product Evaluation Scale (scale range of 1 [not at all] to 7 [extremely])

Maximum response to the Future Intent to Use the Product Questionnaire (visual analog scale range of "definitely would not" to "definitely would")

Change in mass of e-cigarette pods/cartridges

Number of puffs taken during ad libitum use session

Safety and tolerability will be assessed by monitoring the incidence of product-use emergent adverse events.

The study is open label; however, subjects will be masked to the percentage of nicotine in JUUL products.

JUUL 5% Virginia Tobacco flavored ENDS product [6 days] in confinement.

JUUL 3% Virginia Tobacco flavored ENDS product [6 days] in confinement.

JUUL 5% Mint flavored ENDS product [6 days] in confinement.

JUUL 3% Mint flavored ENDS product [6 days] in confinement.

JUUL 5% Menthol flavored ENDS product [6 days] in confinement.

JUUL 3% Menthol flavored ENDS product [6 days] in confinement.

JUUL 5% Mango flavored ENDS product [6 days] in confinement.

JUUL 3% Mango flavored ENDS product [6 days] in confinement.

JUUL 5% Virginia Tobacco, Mint, Menthol, or Mango flavored ENDS product and usual brand of combustible cigarette [6 days] in confinement.

Usual brand combustible cigarette [6 days] in confinement.

Smoking abstention (no smoking) [6 days] in confinement.

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 JUUL 3% Mint ENDS

Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS

Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS

Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS

Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement

Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette

Tobacco/Nicotine Abstention

Continue smoking UB for 6-days in confinement.

Usual Brand of cigarettes

Woodland International Research Group

Woodland Research Northwest

St. Louis Clinical Trials

Midwest Clinical Research Center

Endeavor Clinical Trials

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 Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

Excretion of urine total NNAL, 3-HPMA, MHBMA, and S-PMA will be assessed at baseline and following a 6-day interventional period.

Exposure to carbon monoxide will be assessed through measurement of blood COHb at baseline and following a 6-day interventional period.

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.

Subjective product assessments as measured by responses to the Modified Product Evaluation Scale will be made at baseline and during the interventional period.

The degree to which subjects like the product will be assessed using the Product-Liking Questionnaire at baseline and during the interventional period.

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.

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.

Daily consumption of the JUUL products as measured by the change in pod weight after use during the interventional period will be reported.

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.

Subjects randomized to Group 1 will use JUUL ENDS Virginia Tobacco and Menthol flavors

Subjects randomized to Group 2 will use JUUL ENDS Mint and Mango flavors

JUUL ENDS - Virginia Tobacco 5% nicotine strength

JUUL ENDS - Virginia Tobacco 3% nicotine strength

JUUL ENDS - Menthol 5% nicotine strength

JUUL ENDS - Menthol 3% nicotine strength

JUUL ENDS - Mint 5% nicotine strength

JUUL ENDS - Mint 3% nicotine strength

JUUL ENDS - Mango 5% nicotine strength

JUUL ENDS - Mango 3% nicotine strength

Los Angeles Clinical Trials

Battelle Public Health Lab

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

A Randomized, Open-Label, Cross-Over Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers

To characterize post-acclimatization mean and total puff duration

To characterize post-acclimatization mean and total puff volume

To characterize post-acclimatization mean and peak puff flow rate

To characterize post-acclimatization mean and total inter-puff interval

To characterize post-acclimatization total number of puffs

To measure product weight changes during each puff topography session

To measure number of pods started each day during the ambulatory period

To measure number of puffs per day during the ambulatory period

To assess the relationship between puff topography parameters and JUUL ENDS liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (A Great Deal) in response to the instruction "Please indicate on the line below how much you liked the electronic cigarette product you used during this topography session."

To assess the relationship between puff topography parameters and JUUL ENDS product evaluation using a "Modified Product Evaluation Scale". Scale consists of 21 questions that are categorized into four multi-item sub-scales: (1) "Satisfaction" (items 1, 2, 3, and 12); (2) "Psychological Reward" (items 4 through 8); (3) "Aversion" (items 9, 10, 16, and 18); and (4) "Relief" (item 11, 13, 14, 15, and reversed for item 20). Items 17 and 21 will be summarized individually.

Battelle Memorial Institute

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 .

mangifera/− nikotyna

Evaluating Selected Constituents in the Exhaled Breath Samples

Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

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

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

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