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

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

Conditions

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

Interventions

OTHER

Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS

JUUL 5%, ENDS for 6-days in confinement

OTHER

Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS

JUUL 3%, ENDS for 6-days in confinement

OTHER

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

JUUL 5%, ENDS for 6-days in confinement

OTHER

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

JUUL 3%, ENDS for 6-days in confinement

OTHER

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

JUUL 5%, ENDS for 6-days in confinement

OTHER

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

JUUL 3%, ENDS for 6-days in confinement

OTHER

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

JUUL 5%, ENDS for 6-days in confinement

OTHER

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

JUUL 3%, ENDS for 6-days in confinement

OTHER

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

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

OTHER

Tobacco/Nicotine Abstention

No smoking for 6-days in confinement.

OTHER

Usual Brand of cigarettes

Continue smoking UB for 6-days in confinement.

Sponsors & Collaborators

• Juul Labs, Inc.

  lead INDUSTRY

Principal Investigators

• Mark Rubinstein, MD · Juul Labs, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-17

Primary Completion

2020-02-17

Completion

2020-06-24

Countries

• United States

Study Locations