Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers
A Randomized, Open-Label, Cross-Over Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers
1 other identifier
interventional
56
1 country
2
Brief Summary
A randomized, open label, 2-group, 4-period cross-over study in adult closed system ENDS consumers designed to evaluate puff topography parameters with use of JUUL ENDS products (Virginia Tobacco, Menthol, Mint, and Mango flavors, each at 5% and 3% nicotine strengths).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2020
CompletedJune 14, 2021
February 1, 2020
3 months
September 6, 2019
June 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Puff Topography Parameter - Puff Duration
To characterize post-acclimatization mean and total puff duration
29 Days
Puff Topography Parameter - Puff Volume
To characterize post-acclimatization mean and total puff volume
29 Days
Puff Topography Parameter - Flow Rate
To characterize post-acclimatization mean and peak puff flow rate
29 Days
Puff Topography Parameter - Inter-puff interval
To characterize post-acclimatization mean and total inter-puff interval
29 Days
Puff Topography Parameter - Number of Puffs
To characterize post-acclimatization total number of puffs
29 Days
Secondary Outcomes (5)
Product Use - Product Weight Changes
29 Days
Product Use - Number of Pods Started Each Day
29 Days
Product Use - Number of Puffs Per Day
29 Days
Subjective Measure of product liking
29 Days
Subjective Measure of product evaluation
29 Days
Study Arms (2)
Group 1 - Virginia Tobacco and Menthol
EXPERIMENTALSubjects randomized to Group 1 will use JUUL ENDS Virginia Tobacco and Menthol flavors
Group 2 - Mint and Mango
EXPERIMENTALSubjects randomized to Group 2 will use JUUL ENDS Mint and Mango flavors
Interventions
JUUL ENDS - Virginia Tobacco 5% nicotine strength
JUUL ENDS - Virginia Tobacco 3% nicotine strength
JUUL ENDS - Menthol 5% nicotine strength
JUUL ENDS - Menthol 3% nicotine strength
JUUL ENDS - Mint 5% nicotine strength
JUUL ENDS - Mint 3% nicotine strength
JUUL ENDS - Mango 5% nicotine strength
JUUL ENDS - Mango 3% nicotine strength
Eligibility Criteria
You may qualify if:
- Provides voluntary consent to participate in this study documented on the signed informed consent form (ICF).
- Male or female, 21 to 65 years of age, inclusive, at Screening.
- Has been a closed system ENDS consumer for at least 3 months prior to Screening.
- Currently consumes at least half a pod or cartomizer e-liquid per day as reported at Screening.
- Has a positive urine cotinine (≥200 ng/mL) at Screening.
- Has an exhaled CO \<8 ppm at Screening.
- 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:
- hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Screening; double barrier method (e.g., condom with spermicide, diaphragm with spermicide) at Screening; intrauterine device for at least 3 months prior to Screening; a partner who has been vasectomized for at least 6 months prior to Screening; abstinence beginning at least 6 months prior to Screening.
- A female subject of non childbearing potential must be postmenopausal with amenorrhea for at least 1 year prior to Screening and follicle stimulating hormone (FSH) levels consistent with postmenopausal status or have undergone one of the following sterilization procedures at least 6 months prior to Screening:
- hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy.
- Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.
You may not qualify if:
- Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of an Investigator.
- Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Baseline.
- Has a fever (\>100.5°F) at Screening or Baseline.
- Has a body mass index (BMI) \>40.0 kg/m2 or \<18.0 kg/m2 at Screening.
- Has a history of drug or alcohol abuse within 24 months of Screening, as determined by the Investigator.
- Has or has a history of diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
- Has a systolic blood pressure \<90 or \>150 mmHg, diastolic blood pressure \<40 or \>95 mmHg, or heart rate \<40 or \>99 bpm at Screening.
- Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavor, benzoic acid, propylene glycol and glycerol).
- Has a positive urine screen for alcohol or drugs of abuse at Screening or Baseline.
- If female, the subject is pregnant, has a positive urine pregnancy test at screening, is lactating, or intends to become pregnant during the time period from screening through the end of study.
- Has used any nicotine-containing product other than closed-system ENDS products (e.g., cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Baseline.
- Has used any prescription cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 3 months prior to Screening.
- Negative response (i.e., unwilling to use or unable to tolerate; e.g., experiences AEs during the product trial that will prevent the subjects from continuing to use the study products as judged by the Investigator) to any of the JUUL products at Screening.
- Is a self-reported puffer (i.e., draws aerosol into the mouth and throat but do not inhale).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Juul Labs, Inc.lead
- Los Angeles Clinical Trialscollaborator
- Battelle Memorial Institutecollaborator
Study Sites (2)
Los Angeles Clinical Trials
Burbank, California, 91505, United States
Battelle Public Health Lab
Baltimore, Maryland, 21209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 12, 2019
Study Start
October 28, 2019
Primary Completion
January 23, 2020
Study Completion
January 23, 2020
Last Updated
June 14, 2021
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD to other researchers.