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

Study Overview
=================
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.

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

Conditions
-----------------
Tobacco Use, Nicotine Dependence, Other Tobacco Product, Tobacco Smoking

Intervention / Treatment
-----------------
* Other: JUUL 5%, Virginia Tobacco, ENDS product


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JUUL 5%, Virginia Tobacco, ENDS product<br>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<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electronic Nicotine Delivery System (ENDS), ENDS, Puff Topography