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

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

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Tobacco Smoking; Nicotine Dependence, Other Tobacco Product
• Intervention / Treatment: Other: JUUL 5%, Virginia Tobacco, ENDS product

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28262
      • Rose Research Center Charlotte
    • Raleigh, North Carolina, United States, 27617
      • Rose Research Center Raleigh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: JUUL 5%, Virginia Tobacco, ENDS product; 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 combustibles per day (CPD) throughout the 15 day product use period.	Other: JUUL 5%, Virginia Tobacco, ENDS product; 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.; Other Names: ENDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puff Topography Parameter - Puff Duration	To characterize overall puff duration	15 days
Puff Topography Parameter - Puff Volume	To characterize overall puff volume	15 days
Puff Topography Parameter - Peak Puff Flow Rate	To characterize overall peak puff flow rate	15 days
Puff Topography Parameter - Average Puff Flow Rate	To characterize overall average puff flow	15 days
Puff Topography Parameter - Inter-Puff Interval	To characterize overall inter-puff interval (time between puffs)	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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."	15 days
Subjective measure of cigarette dependence	Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.	15 days
Subjective measure of smoking urges	Assessment of current smoking urge with "Questionnaire of Smoking Urges - Brief (QAU-B)". Responses to various statements with scale 1 (Strongly Disagree) to 7 (Strongly Agree).	15 days
Subjective measure of effects of nicotine	Assessment of nicotine using the "Direct Effects of Nicotine Scale." Visual analogue scale with scale 0 (Not at All) to 100 (Extremely) in response to words describing how the subject feels.	15 days
Subject measure of affect	Assessment of affect using the "Positive and Negative Affect Scale (PANAS)". Scale consists of a number of words that describe different feelings and emotions. Scale 1 (Very Slightly or Not at All), 2 (A Little), 3 (Moderately), 4 (Quite a Bit), 5 (Extremely).	15 days
Subjective measure of nicotine withdrawal	Assessment of nicotine withdrawal using the "Nicotine Withdrawal Scale (MNWS-R)." Scale consists of 15 words/statements that describe different feelings. Scale 0 (None) to 4 (Severe).	15 days

Collaborators and Investigators

• Sponsor: Juul Labs, Inc.
• Collaborators: Rose Research Center, LLC
• Investigators: Principal Investigator: Jed Rose, MD, Rose Research Center, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 9, 2018
• Primary Completion (ACTUAL): September 26, 2018
• Study Completion (ACTUAL): September 26, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: ENDS; Electronic Nicotine Delivery System (ENDS); Puff Topography
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: Protocol No.755-00042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No