A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

Juul Labs, Inc.30 enrolled

Overview

A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5% ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of the study is 15 days with up to a 28 days screening window.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Tobacco Use Nicotine Dependence, Other Tobacco Product Tobacco Smoking

Interventions

JUUL 5%, Virginia Tobacco, ENDS productOTHER

Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Healthy, adult, male or female smoker, 21 to 65 years of age 2. Has been a smoker for at least 12 months prior to Screening. 3. Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day. 4. A female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study 5. Provides voluntary consent to participate in this study documented on the signed informed consent form. Key Exclusion Criteria: 1. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI. 2. Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening. 3. Has a history of drug or alcohol abuse within 24 months of Day 1. 4. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.

Locations (2)

Rose Research Center Charlotte

Charlotte, North Carolina, United States

Rose Research Center Raleigh

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

Puff Topography Parameter - Puff Duration

To characterize overall puff duration

Time frame: 15 days

Puff Topography Parameter - Puff Volume

To characterize overall puff volume

Time frame: 15 days

Puff Topography Parameter - Peak Puff Flow Rate

To characterize overall peak puff flow rate

Time frame: 15 days

Puff Topography Parameter - Average Puff Flow Rate

To characterize overall average puff flow

Time frame: 15 days

Puff Topography Parameter - Inter-Puff Interval

To characterize overall inter-puff interval (time between puffs)

Time frame: 15 days

Secondary Outcomes

Self-reported product use over 15-day period

To assess the relationship between puff topography parameters and self-reported product use (number of puffs per day and number of JUULpods started each day) in a 15-day product use period.

Time frame: 15 days

Subjective measure of product liking

To assess the relationship between puff topography parameters and JUUL 5% ENDs liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (Extremely) in response to question "I like using the JUUL Product."

Time frame: 15 days

Subjective measure of cigarette dependence

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.