A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
- Conditions
- Nicotine Dependence, Other Tobacco ProductTobacco UseTobacco Smoking
- Interventions
- Other: JUUL 5%, Virginia Tobacco, ENDS product
- Registration Number
- NCT03596034
- Lead Sponsor
- Juul Labs, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JUUL 5%, Virginia Tobacco, ENDS product 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.
- Primary Outcome Measures
Name Time Method Puff Topography Parameter - Average Puff Flow Rate 15 days To characterize overall average puff flow
Puff Topography Parameter - Puff Duration 15 days To characterize overall puff duration
Puff Topography Parameter - Peak Puff Flow Rate 15 days To characterize overall peak puff flow rate
Puff Topography Parameter - Inter-Puff Interval 15 days To characterize overall inter-puff interval (time between puffs)
Puff Topography Parameter - Puff Volume 15 days To characterize overall puff volume
- Secondary Outcome Measures
Name Time Method Subjective measure of product liking 15 days 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."
Subject measure of affect 15 days 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).
Self-reported product use over 15-day period 15 days 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 cigarette dependence 15 days Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.
Subjective measure of nicotine withdrawal 15 days 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).
Subjective measure of smoking urges 15 days 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 15 days 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.
Trial Locations
- Locations (2)
Rose Research Center Raleigh
🇺🇸Raleigh, North Carolina, United States
Rose Research Center Charlotte
🇺🇸Charlotte, North Carolina, United States