Electronic Cigarette UseNCT04088175
Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers
A study testing JUUL ENDS - Virginia Tobacco 5% nicotine strength, JUUL ENDS - Virginia Tobacco 3% nicotine strength and JUUL ENDS - Menthol 5% nicotine strength in people with Electronic Cigarette Use, run by Juul Labs, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- JUUL ENDS - Virginia Tobacco 5% nicotine strength, JUUL ENDS - Virginia Tobacco 3% nicotine strength and JUUL ENDS - Menthol 5% nicotine strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2019to 23 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Is planning to quit ENDS product use during the study or postponing (within 30 days of screening) a quit attempt in order to participate in the study.
- Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Screening.
- Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of the study site.
- Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee, shareholder, or is member of the board of directors of JUUL Labs Inc.
- Has previously taken part in, has been excluded or withdrawn from, or has completed this study.
- In the opinion of the Investigator, the subject should not participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Battelle Public Health Lab
Baltimore, Maryland, 21209
Los Angeles Clinical Trials
Burbank, California, 91505
About this study
Official title: 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
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).
Read the detailed description
Subjects who successfully complete screening procedures, including a brief trial with each of the JUUL flavors at the 5% strength, will be eligible to participate in the study.
Subjects will be randomized into one of two (2) groups (Virginia Tobacco and Menthol or Mint and Mango, each at both nicotine strengths) and to one of four (4) product use sequences specifying the order for which they will use the assigned products.
Apart from the final in-clinic visit, study visits will include two puff topography sessions; each session will be separated by 2 hours (minimum) after completion of the previous topography session. Puff topography sessions will include 1 hour of ad libitum product use according to the subject's usual ENDS product use procedures. A Baseline topography session will be done using the subject's usual ENDS product to provide context to the JUUL results. The Baseline session will be followed by a topography session with a JUUL product. Subsequent clinic visits will include two different JUUL products: (1) The JUUL product used during the current study period and (2) The JUUL product for the next study period. The final in-clinic visit will only include one puff topography session with the JUUL product used during the final study period.
Puff topography measurements will be collected with a Clinical Research Support System (CReSS) device. Subjects who present with a preferred ENDS product that is not compatible with adapters fitting the CReSS device will participate in the 1 hour product use session without using the CReSS device. The weight of the product (pod/cartomizer without the battery; resolution of 0.1 mg) will be measured before and after use.
Subjects will complete subjective effects questionnaires (Product Liking and PES) after completion of each topography session. The subjective effects questionnaires and product use data will be used to assess potential factors that might impact the puff topography parameters.
After completion of required study events at each clinic visit, subjects will be discharged with a 7-day supply of the appropriate JUUL product and with instructions that the provided product is the only tobacco/nicotine containing product that they are to use, and to reach out to the clinic if it appears that they will run out of JUUL products before the next clinic visit. Subjects will be also be asked to complete an at-home product use log each day until returning to the clinic.
- Conditions
- Electronic Cigarette Use
- Being tested
- 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
- Keywords
- Topography
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL ENDS - Virginia Tobacco 5% nicotine strengthOther
JUUL ENDS - Virginia Tobacco 5% nicotine strength
JUUL ENDS - Virginia Tobacco 3% nicotine strengthOther
JUUL ENDS - Virginia Tobacco 3% nicotine strength
JUUL ENDS - Menthol 5% nicotine strengthOther
JUUL ENDS - Menthol 5% nicotine strength
JUUL ENDS - Menthol 3% nicotine strengthOther
JUUL ENDS - Menthol 3% nicotine strength
JUUL ENDS - Mint 5% nicotine strengthOther
JUUL ENDS - Mint 5% nicotine strength
JUUL ENDS - Mint 3% nicotine strengthOther
JUUL ENDS - Mint 3% nicotine strength
JUUL ENDS - Mango 5% nicotine strengthOther
JUUL ENDS - Mango 5% nicotine strength
JUUL ENDS - Mango 3% nicotine strengthOther
JUUL ENDS - Mango 3% nicotine strength
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Virginia Tobacco and Menthol | Experimental | Subjects randomized to Group 1 will use JUUL ENDS Virginia Tobacco and Menthol flavors Receives: Other: JUUL ENDS - Virginia Tobacco 5% nicotine strength; Other: JUUL ENDS - Virginia Tobacco 3% nicotine strength; Other: JUUL ENDS - Menthol 5% nicotine strength; Other: JUUL ENDS - Menthol 3% nicotine strength |
| Group 2 - Mint and Mango | Experimental | Subjects randomized to Group 2 will use JUUL ENDS Mint and Mango flavors Receives: Other: JUUL ENDS - Mint 5% nicotine strength; Other: JUUL ENDS - Mint 3% nicotine strength; Other: JUUL ENDS - Mango 5% nicotine strength; Other: JUUL ENDS - Mango 3% nicotine strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff Topography Parameter - Puff Duration
To characterize post-acclimatization mean and total puff duration
Measured: 29 Days
Puff Topography Parameter - Puff Volume
To characterize post-acclimatization mean and total puff volume
Measured: 29 Days
Puff Topography Parameter - Flow Rate
To characterize post-acclimatization mean and peak puff flow rate
Measured: 29 Days
Puff Topography Parameter - Inter-puff interval
To characterize post-acclimatization mean and total inter-puff interval
Measured: 29 Days
Puff Topography Parameter - Number of Puffs
To characterize post-acclimatization total number of puffs
Measured: 29 Days
Secondary outcomes (5)
Product Use - Product Weight Changes
To measure product weight changes during each puff topography session
Measured: 29 Days
Product Use - Number of Pods Started Each Day
To measure number of pods started each day during the ambulatory period
Measured: 29 Days
Product Use - Number of Puffs Per Day
To measure number of puffs per day during the ambulatory period
Measured: 29 Days
Subjective Measure of product liking
To assess the relationship between puff topography parameters and JUUL ENDS liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (A Great Deal) in response to the instruction "Please indicate on the line below how much you liked the electronic cigarette product you used during this topography session."
Measured: 29 Days
Subjective Measure of product evaluation
To assess the relationship between puff topography parameters and JUUL ENDS product evaluation using a "Modified Product Evaluation Scale". Scale consists of 21 questions that are categorized into four multi-item sub-scales: (1) "Satisfaction" (items 1, 2, 3, and 12); (2) "Psychological Reward" (items 4 through 8); (3) "Aversion" (items 9, 10, 16, and 18); and (4) "Relief" (item 11, 13, 14, 15, and reversed for item 20). Items 17 and 21 will be summarized individually.
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start28 Oct 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 .
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Los Angeles Clinical Trials, Battelle Memorial Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088175
- Sponsor's protocol ID
- PROT-00032
- Status last verified
- Feb 2020
- First submitted
- 6 Sep 2019
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04088175
- Acronym / sponsor ID
- PROT-00032
- Conditions
- Electronic Cigarette Use
- Keywords
- Topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Los Angeles Clinical Trials, Battelle Memorial Institute
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subjects who successfully complete screening procedures, including a brief trial with each of the JUUL flavors at the 5% strength, will be eligible to participate in the study.
Subjects will be randomized into one of two (2) groups (Virginia Tobacco and Menthol or Mint and Mango, each at both nicotine strengths) and to one of four (4) product use sequences specifying the order for which they will use the assigned products.
Apart from the final in-clinic visit, study visits will include two puff topography sessions; each session will be separated by 2 hours (minimum) after completion of the previous topography session. Puff topography sessions will include 1 hour of ad libitum product use according to the subject's usual ENDS product use procedures. A Baseline topography session will be done using the subject's usual ENDS product to provide context to the JUUL results. The Baseline session will be followed by a topography session with a JUUL product. Subsequent clinic visits will include two different JUUL products: (1) The JUUL product used during the current study period and (2) The JUUL product for the next study period. The final in-clinic visit will only include one puff topography session with the JUUL product used during the final study period.
Puff topography measurements will be collected with a Clinical Research Support System (CReSS) device. Subjects who present with a preferred ENDS product that is not compatible with adapters fitting the CReSS device will participate in the 1 hour product use session without using the CReSS device. The weight of the product (pod/cartomizer without the battery; resolution of 0.1 mg) will be measured before and after use.
Subjects will complete subjective effects questionnaires (Product Liking and PES) after completion of each topography session. The subjective effects questionnaires and product use data will be used to assess potential factors that might impact the puff topography parameters.
After completion of required study events at each clinic visit, subjects will be discharged with a 7-day supply of the appropriate JUUL product and with instructions that the provided product is the only tobacco/nicotine containing product that they are to use, and to reach out to the clinic if it appears that they will run out of JUUL products before the next clinic visit. Subjects will be also be asked to complete an at-home product use log each day until returning to the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Virginia Tobacco and Menthol | Experimental | Other: JUUL ENDS - Virginia Tobacco 5% nicotine strength, Other: JUUL ENDS - Virginia Tobacco 3% nicotine strength, Other: JUUL ENDS - Menthol 5% nicotine strength, Other: JUUL ENDS - Menthol 3% nicotine strengthSubjects randomized to Group 1 will use JUUL ENDS Virginia Tobacco and Menthol flavors |
| Group 2 - Mint and Mango | Experimental | Other: JUUL ENDS - Mint 5% nicotine strength, Other: JUUL ENDS - Mint 3% nicotine strength, Other: JUUL ENDS - Mango 5% nicotine strength, Other: JUUL ENDS - Mango 3% nicotine strengthSubjects randomized to Group 2 will use JUUL ENDS Mint and Mango flavors |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUUL ENDS - Virginia Tobacco 5% nicotine strengthJUUL ENDS - Virginia Tobacco 5% nicotine strength | Other | Group 1 - Virginia Tobacco and Menthol |
| JUUL ENDS - Virginia Tobacco 3% nicotine strengthJUUL ENDS - Virginia Tobacco 3% nicotine strength | Other | Group 1 - Virginia Tobacco and Menthol |
| JUUL ENDS - Menthol 5% nicotine strengthJUUL ENDS - Menthol 5% nicotine strength | Other | Group 1 - Virginia Tobacco and Menthol |
| JUUL ENDS - Menthol 3% nicotine strengthJUUL ENDS - Menthol 3% nicotine strength | Other | Group 1 - Virginia Tobacco and Menthol |
| JUUL ENDS - Mint 5% nicotine strengthJUUL ENDS - Mint 5% nicotine strength | Other | Group 2 - Mint and Mango |
| JUUL ENDS - Mint 3% nicotine strengthJUUL ENDS - Mint 3% nicotine strength | Other | Group 2 - Mint and Mango |
| JUUL ENDS - Mango 5% nicotine strengthJUUL ENDS - Mango 5% nicotine strength | Other | Group 2 - Mint and Mango |
| JUUL ENDS - Mango 3% nicotine strengthJUUL ENDS - Mango 3% nicotine strength | Other | Group 2 - Mint and Mango |
Primary outcome
Puff Topography Parameter - Puff Duration
Time frame: 29 Days
To characterize post-acclimatization mean and total puff duration
Puff Topography Parameter - Puff Volume
Time frame: 29 Days
To characterize post-acclimatization mean and total puff volume
Puff Topography Parameter - Flow Rate
Time frame: 29 Days
To characterize post-acclimatization mean and peak puff flow rate
Puff Topography Parameter - Inter-puff interval
Time frame: 29 Days
To characterize post-acclimatization mean and total inter-puff interval
Puff Topography Parameter - Number of Puffs
Time frame: 29 Days
To characterize post-acclimatization total number of puffs
5 secondary outcomes
Product Use - Product Weight Changes
Time frame: 29 Days
Product Use - Number of Pods Started Each Day
Time frame: 29 Days
Product Use - Number of Puffs Per Day
Time frame: 29 Days
Subjective Measure of product liking
Time frame: 29 Days
Subjective Measure of product evaluation
Time frame: 29 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: No. There is no plan to share IPD to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUUL ENDS - Virginia Tobacco 5% nicotine strength, JUUL ENDS - Virginia Tobacco 3% nicotine strength and JUUL ENDS - Menthol 5% nicotine strength in people with Electronic Cigarette Use, run by Juul Labs, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puff Topography Parameter - Puff Duration (time frame: 29 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.