Clinical trial NCT03596034: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Nicotine Dependence, Other Tobacco Product
Tobacco Smoking
Keywords: Electronic Nicotine Delivery System (ENDS)
ENDS
Puff Topography
Lead sponsor: Juul Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rose Research Center, LLC
First posted: 2018-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Puff Topography Parameter - Puff Duration
timeFrame: 15 days
measure: Puff Topography Parameter - Puff Volume
timeFrame: 15 days
measure: Puff Topography Parameter - Peak Puff Flow Rate
timeFrame: 15 days
measure: Puff Topography Parameter - Average Puff Flow Rate
timeFrame: 15 days
measure: Puff Topography Parameter - Inter-Puff Interval
timeFrame: 15 days
Secondary outcomes:
measure: Self-reported product use over 15-day period
timeFrame: 15 days
measure: Subjective measure of product liking
timeFrame: 15 days
measure: Subjective measure of cigarette dependence
timeFrame: 15 days
measure: Subjective measure of smoking urges
timeFrame: 15 days
measure: Subjective measure of effects of nicotine
timeFrame: 15 days
measure: Subject measure of affect
timeFrame: 15 days
measure: Subjective measure of nicotine withdrawal
timeFrame: 15 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Rose Research Center Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Rose Research Center Raleigh
state: North Carolina
Study officials:
affiliation: Rose Research Center, LLC
name: Jed Rose, MD
role: PRINCIPAL_INVESTIGATOR
References: