Back to resultsA Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Primary Purpose
Tobacco Use, Nicotine Dependence, Other Tobacco Product, Tobacco Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JUUL 5%, Virginia Tobacco, ENDS product
Sponsored by
About this trial
This is an interventional other trial for Tobacco Use focused on measuring Electronic Nicotine Delivery System (ENDS), ENDS, Puff Topography
Eligibility Criteria
Key Inclusion Criteria:
- Healthy, adult, male or female smoker, 21 to 65 years of age
- Has been a smoker for at least 12 months prior to Screening.
- Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
- 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
- Provides voluntary consent to participate in this study documented on the signed informed consent form.
Key Exclusion Criteria:
- 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.
- Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening.
- Has a history of drug or alcohol abuse within 24 months of Day 1.
- If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
Sites / Locations
- Rose Research Center Charlotte
- Rose Research Center Raleigh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JUUL 5%, Virginia Tobacco, ENDS product
Arm Description
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.
Outcomes
Primary Outcome Measures
Puff Topography Parameter - Puff Duration
To characterize overall puff duration
Puff Topography Parameter - Puff Volume
To characterize overall puff volume
Puff Topography Parameter - Peak Puff Flow Rate
To characterize overall peak puff flow rate
Puff Topography Parameter - Average Puff Flow Rate
To characterize overall average puff flow
Puff Topography Parameter - Inter-Puff Interval
To characterize overall inter-puff interval (time between puffs)
Secondary Outcome Measures
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.
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."
Subjective measure of cigarette dependence
Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.
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).
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.
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).
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).
Full Information
NCT ID
NCT03596034
First Posted
June 6, 2018
Last Updated
June 10, 2021
Sponsor
Juul Labs, Inc.
Collaborators
Rose Research Center, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03596034
Brief Title
A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Official Title
A Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juul Labs, Inc.
Collaborators
Rose Research Center, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Nicotine Dependence, Other Tobacco Product, Tobacco Smoking
Keywords
Electronic Nicotine Delivery System (ENDS), ENDS, Puff Topography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JUUL 5%, Virginia Tobacco, ENDS product
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
JUUL 5%, Virginia Tobacco, ENDS product
Other Intervention Name(s)
ENDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Puff Topography Parameter - Puff Duration
Description
To characterize overall puff duration
Time Frame
15 days
Title
Puff Topography Parameter - Puff Volume
Description
To characterize overall puff volume
Time Frame
15 days
Title
Puff Topography Parameter - Peak Puff Flow Rate
Description
To characterize overall peak puff flow rate
Time Frame
15 days
Title
Puff Topography Parameter - Average Puff Flow Rate
Description
To characterize overall average puff flow
Time Frame
15 days
Title
Puff Topography Parameter - Inter-Puff Interval
Description
To characterize overall inter-puff interval (time between puffs)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Self-reported product use over 15-day period
Description
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
Title
Subjective measure of product liking
Description
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
Title
Subjective measure of cigarette dependence
Description
Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.
Time Frame
15 days
Title
Subjective measure of smoking urges
Description
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).
Time Frame
15 days
Title
Subjective measure of effects of nicotine
Description
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.
Time Frame
15 days
Title
Subject measure of affect
Description
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).
Time Frame
15 days
Title
Subjective measure of nicotine withdrawal
Description
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).
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
Healthy, adult, male or female smoker, 21 to 65 years of age
Has been a smoker for at least 12 months prior to Screening.
Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
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
Provides voluntary consent to participate in this study documented on the signed informed consent form.
Key Exclusion Criteria:
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.
Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening.
Has a history of drug or alcohol abuse within 24 months of Day 1.
If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jed Rose, MD
Organizational Affiliation
Rose Research Center, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rose Research Center Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Rose Research Center Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
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