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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596034
• Other study ID #: Protocol No.755-00042
• Status: Completed
• Phase: N/A
• Start date: August 9, 2018
• Est. completion date: September 26, 2018

Study information

• Verified date: October 2018
• Source: Juul Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence, Other Tobacco Product
• Tobacco Smoking
• Tobacco Use
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Rose Research Center Charlotte	Charlotte	North Carolina
United States	Rose Research Center Raleigh	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Juul Labs, Inc.	Rose Research Center, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puff Topography Parameter - Puff Duration	To characterize overall puff duration	15 days
Primary	Puff Topography Parameter - Puff Volume	To characterize overall puff volume	15 days
Primary	Puff Topography Parameter - Peak Puff Flow Rate	To characterize overall peak puff flow rate	15 days
Primary	Puff Topography Parameter - Average Puff Flow Rate	To characterize overall average puff flow	15 days
Primary	Puff Topography Parameter - Inter-Puff Interval	To characterize overall inter-puff interval (time between puffs)	15 days
Secondary	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
Secondary	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
Secondary	Subjective measure of cigarette dependence	Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.	15 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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