Tobacco UseNCT03596034
A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
A study testing JUUL 5%, Virginia Tobacco, ENDS product in people with Tobacco Use and Nicotine Dependence, Other Tobacco Product, run by Juul Labs, Inc. at 2 sites in United States.
Trial summary
A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Nicotine Dependence, Other Tobacco Product, Tobacco Smoking
- What is being tested?
- JUUL 5%, Virginia Tobacco, ENDS product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2018to 26 Sep 2018
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rose Research Center Charlotte
Charlotte, North Carolina, 28262
Rose Research Center Raleigh
Raleigh, North Carolina, 27617
About this study
Official title: A Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Read the 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.
- Being tested
- JUUL 5%, Virginia Tobacco, ENDS product
- Keywords
- Electronic Nicotine Delivery System (ENDS), ENDS, Puff Topography
- Medical subject headings
- Tobacco Use, Tobacco Use Disorder, Tobacco Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL 5%, Virginia Tobacco, ENDS productOther
Also called ENDS
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.
| Study group | Role | What they receive |
|---|---|---|
| JUUL 5%, Virginia Tobacco, ENDS product | Experimental | 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. Receives: Other: JUUL 5%, Virginia Tobacco, ENDS product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff Topography Parameter - Puff Duration
To characterize overall puff duration
Measured: 15 days
Puff Topography Parameter - Puff Volume
To characterize overall puff volume
Measured: 15 days
Puff Topography Parameter - Peak Puff Flow Rate
To characterize overall peak puff flow rate
Measured: 15 days
Puff Topography Parameter - Average Puff Flow Rate
To characterize overall average puff flow
Measured: 15 days
Puff Topography Parameter - Inter-Puff Interval
To characterize overall inter-puff interval (time between puffs)
Measured: 15 days
Secondary outcomes (7)
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.
Measured: 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."
Measured: 15 days
Subjective measure of cigarette dependence
Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start9 Aug 2018
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juul Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rose Research Center, LLC
- Responsible party
- Sponsor
- Investigators
- Jed Rose, MD, Principal investigator, Rose Research Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596034
- Sponsor's protocol ID
- Protocol No.755-00042
- Status last verified
- Oct 2018
- First submitted
- 6 Jun 2018
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
- ClinicalTrials.gov ID
- NCT03596034
- Acronym / sponsor ID
- Protocol No.755-00042
- Keywords
- Electronic Nicotine Delivery System (ENDS), ENDS, Puff Topography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Juul Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rose Research Center, LLC
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 23 Jul 2018 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUUL 5%, Virginia Tobacco, ENDS product | Experimental | Other: JUUL 5%, Virginia Tobacco, ENDS productSubjects 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- 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.
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 5%, Virginia Tobacco, ENDS productAlso: ENDSSubjects 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. | Other | JUUL 5%, Virginia Tobacco, ENDS product |
Primary outcome
Puff Topography Parameter - Puff Duration
Time frame: 15 days
To characterize overall puff duration
Puff Topography Parameter - Puff Volume
Time frame: 15 days
To characterize overall puff volume
Puff Topography Parameter - Peak Puff Flow Rate
Time frame: 15 days
To characterize overall peak puff flow rate
Puff Topography Parameter - Average Puff Flow Rate
Time frame: 15 days
To characterize overall average puff flow
Puff Topography Parameter - Inter-Puff Interval
Time frame: 15 days
To characterize overall inter-puff interval (time between puffs)
7 secondary outcomes
Self-reported product use over 15-day period
Time frame: 15 days
Subjective measure of product liking
Time frame: 15 days
Subjective measure of cigarette dependence
Time frame: 15 days
Subjective measure of smoking urges
Time frame: 15 days
Subjective measure of effects of nicotine
Time frame: 15 days
Subject measure of affect
Time frame: 15 days
Subjective measure of nicotine withdrawal
Time frame: 15 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: Undecided
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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.
Jed Rose, MD principal investigator
Rose Research Center, LLC
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 5%, Virginia Tobacco, ENDS product in people with Tobacco Use and Nicotine Dependence, Other Tobacco Product, 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 5 inclusion and 4 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: 15 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.