Electronic Cigarette UseNCT04143256

Evaluating Selected Constituents in the Exhaled Breath Samples

A study testing JUUL ENDS 5% Virginia Tobacco, JUUL 3% Virginia Tobacco ENDS and JUUL 5% Mint ENDS in people with Electronic Cigarette Use and Cigarette Use, Electronic, run by Juul Labs, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors) 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, Cigarette Use, Electronic, Tobacco Use
What is being tested?: JUUL ENDS 5% Virginia Tobacco, JUUL 3% Virginia Tobacco ENDS and JUUL 5% Mint ENDS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 3 sitesUnited States
Study dates: 3 Oct 2019to 13 Dec 2019
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

Be a healthy male or female aged 21 - 65 years, inclusive, at the time of signing the informed consent.
Be informed of the nature of the study, agree to and are able to read, review, and sign the informed consent document prior to any study procedures. The informed consent document will only be available in English. Therefore, the volunteer must have the ability to read and communicate in English in order to participate in the study.
Complete the screening process up to 28 days prior to Day 1.
Satisfy the user definitions of either cigarette user or ENDS/closed system user.
Agree to abide by the study restrictions.
Agree to abstain from use of alcohol 12 hours before the start of Day 1 for Groups I through VI.

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Agree to abstain from use of any nicotine products 12 hours before the start of study day 1 for Groups I through VI.
Agree to not consume any mint or menthol flavor products (e.g., chewing gum, mouth wash, toothpaste, etc.) 12 hours before the start of testing for Groups I through VI.
Have a positive urine cotinine result at screening of >200 ng/ml.
A female subject of childbearing potential must have been using one (1) of the following forms of contraception and agree to continue using it through completion of the trial:
hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Day 1;
double barrier method (e.g., condom with spermicide, diaphragm with spermicide) at screening.
intrauterine device for at least 3 months prior to Day 1;
a partner who has been vasectomized for at least 6 months prior to Day 1;
abstinence beginning at least 6 months prior to screening.
A female subject of non childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
hysteroscopic sterilization;
bilateral tubal ligation or bilateral salpingectomy;
hysterectomy;
bilateral oophorectomy;
Or be postmenopausal with amenorrhea for at least 1 year prior to Day 1.
Be judged by the Investigator to be in good general health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments and by general observations. Any abnormalities or deviations outside the normal ranges for any clinical testing (e.g. vital signs) can be repeated at the discretion of the Investigator and judged to be not clinically significant for study participation.

Who cannot join

Report receiving any investigational product, participated in any previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to screening.
Report at screening using both ENDS and conventional cigarettes (menthol or non-menthol) (dual users), or use of other inhaled products (such as, but not limited to cannabis) in the past 3 months.
For ENDS users, be unable to perform CPS or incapable of drawing down the pod weight by 20-60mg after 3 attempts at screening.
If female, be pregnant, have a positive urine pregnancy test at screening, be lactating, breast feeding, or intend to become pregnant during the time period from screening through the end of the study.
Have any clinically significant results from physical examinations and vital signs assessments, as judged by the Investigator.
Have a systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 40 mmHg or > 95 mmHg, or heart rate < 40 bpm or > 99 bpm at screening.

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Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
Report a history of drug or alcohol addiction or abuse within the past 1 year.
Have a positive screen for alcohol or drugs of abuse at screening or at check-in on Day 1.
Have a body mass index (BMI) greater than 40 kg/m2 or less than 18 kg/m2 at screening.
Have used prescription anti-diabetic medication and/or insulin therapy within 12 months of screening.
Have taken medication for depression, asthma, or chronic obstructive pulmonary disease within 6 months of screening.
Have used prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) within 6 months of screening.
Be breast-feeding or pregnant female subjects (confirmed by a positive pregnancy test). Female subjects, who are considered women of child bearing potential (WOCBP) and sexually active, must be willing and able to use an acceptable method of contraception from screening through the end of the study.
Have 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/or glycerol.
Be or have a first-degree relative (i.e. parent, sibling or child) who is a current employee of CRO, Sponsor, or site.
In the opinion of an Investigator, be deemed not eligible to participate in this study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Rose Research Center
Charlotte, North Carolina, 28262
Rose Research Center
Raleigh, North Carolina, 27617
Frontage Clinical Services
Secaucus, New Jersey, 07094

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)

Read the detailed description

The objective of this study is to evaluate the baseline-adjusted level of selected constituents in the exhaled breath sample (EBS) between the two JUUL NSPS products (5% vs 3% nicotine by weight) for Virginia Tobacco, Mint, Mango and Menthol flavor and to compare the change in absolute level of selected constituents in EBS before and after the use of JUUL NSPS (5% and 3% nicotine by weight; Virginia Tobacco, Mint, Mango, Menthol flavors) to the change in absolute level of selected constituents before and after the use of menthol and non-menthol cigarettes.

Subjects will be screened for participation in the trial up to 28 days before Day 1. Along with screening procedures, all subjects will receive training on EBS collection procedures. All subjects will be further trained on the CPS using a training video and site instructions. Trained subjects will have the opportunity to try the JUUL NSPS.

Eligible subjects will be scheduled for a Day 1 clinic visit. Within 24 to 48 hours prior to Check-in, the clinic staff will provide a courtesy phone call to subjects to remind them to abstain from the use of alcohol, any nicotine-containing products and mint/mentholated products for at least 12 hours prior and xanthines/caffeine for at least 24 hours prior to screening and Day 1.

Following completion of the check-in events, including re-instruction on the EBS sample collection technique and CPS instructions, subjects will participate in the exhaled breath collection test sessions.

Groups I - IV will complete two periods of baseline and test sample collections with a 3-hour break in between each period. Each period will consist of two baseline samples (the first for analysis of nicotine, propylene glycol and glycerin and the second for analysis of acetaldehyde, acrolein, benzoic acid, formaldehyde, and menthol), followed by product use, and then two test samples (similar to baseline). Exhaled CO will be measured before the first baseline sample, after the second baseline sample, before the first test sample and after the second test sample. Pods used during the test sessions will be weighed before and after use.

Groups V and VI will complete only one period of baseline and test sample collections, consisting of two baseline sample collections and two test sample collections similar to that noted above.

A follow-up phone call with subjects will be made the day after Check-out (or early withdrawal). Provided there are no adverse events which require further attention, the subject's participation in the trial will be complete.

Conditions: Electronic Cigarette Use, Cigarette Use, Electronic, Tobacco Use, Tobacco Smoking
Being tested: JUUL ENDS 5% Virginia Tobacco, JUUL 3% Virginia Tobacco ENDS, JUUL 5% Mint ENDS, JUUL 3% Mint ENDS, JUUL 5% Menthol ENDS
Keywords: Electronic Nicotine Delivery, Combustible Cigarettes, Nicotine, Exhaled Breath
Medical subject headings: Vaping, Tobacco Use, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JUUL ENDS 5% Virginia TobaccoOther
JUUL ENDS Virginia Tobacco 5% nicotine strength
JUUL 3% Virginia Tobacco ENDSOther
JUUL ENDS Virginia Tobacco 3% nicotine strength
JUUL 5% Mint ENDSOther
JUUL ENDS Mint 5% nicotine strength
JUUL 3% Mint ENDSOther
JUUL ENDS Mint 3% nicotine strength
JUUL 5% Menthol ENDSOther
JUUL ENDS Menthol 5% nicotine strength
JUUL 3% Menthol ENDSOther
JUUL ENDS Menthol 3% nicotine strength
JUUL 5% Mango ENDSOther
JUUL ENDS Mango 5% nicotine strength
JUUL 3% Mango ENDSOther
JUUL ENDS Mango 3% nicotine strength
US Cigarette, Non-menthol - Marlboro Gold King SizeOther
US Cigarette, Non-menthol - Marlboro Gold King Size
US Cigarette, Menthol - Newport King SizeOther
US Cigarette, Menthol - Newport King Size

Study groups in NCT04143256
Study group	Role	What they receive
Group I	Experimental	Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Virginia Tobacco and 3% Virginia Tobacco Receives: Other: JUUL ENDS 5% Virginia Tobacco; Other: JUUL 3% Virginia Tobacco ENDS
Group II	Experimental	Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mint and 3% Mint Receives: Other: JUUL 5% Mint ENDS; Other: JUUL 3% Mint ENDS
Group III	Experimental	Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Menthol and 3% Menthol Receives: Other: JUUL 5% Menthol ENDS; Other: JUUL 3% Menthol ENDS
Group IV	Experimental	Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mango and 3% Mango Receives: Other: JUUL 5% Mango ENDS; Other: JUUL 3% Mango ENDS
Group V	Experimental	Subjects with cigarette user history will be assigned to use US Cigarette, Non-Menthol Flavor (Marlboro Gold King Size) Receives: Other: US Cigarette, Non-menthol - Marlboro Gold King Size
Group VI	Experimental	Subjects with cigarette user history will be assigned to use US Cigarette, Menthol Flavor (Newport King Size) Receives: Other: US Cigarette, Menthol - Newport King Size

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of nicotine for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of propylene glycol for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of vegetable glycerin for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of acetaldehyde for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of acrolein for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of benzoic acid for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of formaldehyde for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of menthol for each subject.
Measured: Up to 6-hours
Evaluate Absolute Change from Baseline Level
The absolute change from baseline level of carbon monoxide for each subject.
Measured: Up to 6-hours

Secondary outcomes (10)

Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of nicotine for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of propylene glycol for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of vegetable glycerin for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of acetaldehyde for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of acrolein for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of benzoic acid for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of formaldehyde for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of menthol for each subject.
Measured: Up to 6-hours
Compare the change between baseline and post-baseline levels
Compare the change between baseline and post-baseline levels of carbon monoxide for each subject.
Measured: Up to 6-hours
Change in weight
Change in the weight of JUUL pods before and after the usage.
Measured: Up to 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201913 Dec 2019

First posted29 Oct 2019
Study start3 Oct 2019
Primary completion12 Dec 2019
Study completion13 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Four crossover groups and two single arm groups
Masking: None (open label)
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143256
Sponsor's protocol ID: PROT-00109
Status last verified: Feb 2020
First submitted: 24 Oct 2019
Last updated: 11 Feb 2020
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.

Publications

Oldham MJ, Bailey PC, Castro N, Lang Q, Salehi A, Rostami AA. Prediction of potential passive exposure from commercial electronic nicotine delivery systems using exhaled breath analysis and computational fluid dynamic techniques. J Breath Res. 2021 Oct 5;15(4). doi: 10.1088/1752-7163/ac2884.
PubMed 34544050

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)
ClinicalTrials.gov ID: NCT04143256
Acronym / sponsor ID: PROT-00109
Conditions: Electronic Cigarette Use, Cigarette Use, Electronic, Tobacco Use, Tobacco Smoking
Keywords: Electronic Nicotine Delivery, Combustible Cigarettes, Nicotine, Exhaled Breath
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Juul Labs, Inc.Industry (pharma, biotech, devices)
Study start: 3 Oct 2019 (actual)
Primary completion: 12 Dec 2019 (actual)
Study completion: 13 Dec 2019 (actual)
First posted: 29 Oct 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.

Detailed description

Groups V and VI will complete only one period of baseline and test sample collections, consisting of two baseline sample collections and two test sample collections similar to that noted above.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: Four crossover groups and two single arm groups

Arm	Type	Receives
Group I	Experimental	Other: JUUL ENDS 5% Virginia Tobacco, Other: JUUL 3% Virginia Tobacco ENDSSubjects with ENDS user history may be randomized to use JUUL ENDS 5% Virginia Tobacco and 3% Virginia Tobacco
Group II	Experimental	Other: JUUL 5% Mint ENDS, Other: JUUL 3% Mint ENDSSubjects with ENDS user history may be randomized to use JUUL ENDS 5% Mint and 3% Mint
Group III	Experimental	Other: JUUL 5% Menthol ENDS, Other: JUUL 3% Menthol ENDSSubjects with ENDS user history may be randomized to use JUUL ENDS 5% Menthol and 3% Menthol
Group IV	Experimental	Other: JUUL 5% Mango ENDS, Other: JUUL 3% Mango ENDSSubjects with ENDS user history may be randomized to use JUUL ENDS 5% Mango and 3% Mango
Group V	Experimental	Other: US Cigarette, Non-menthol - Marlboro Gold King SizeSubjects with cigarette user history will be assigned to use US Cigarette, Non-Menthol Flavor (Marlboro Gold King Size)
Group VI	Experimental	Other: US Cigarette, Menthol - Newport King SizeSubjects with cigarette user history will be assigned to use US Cigarette, Menthol Flavor (Newport King Size)

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Be a healthy male or female aged 21 - 65 years, inclusive, at the time of signing the informed consent.
Be informed of the nature of the study, agree to and are able to read, review, and sign the informed consent document prior to any study procedures. The informed consent document will only be available in English. Therefore, the volunteer must have the ability to read and communicate in English in order to participate in the study.
Complete the screening process up to 28 days prior to Day 1.
Satisfy the user definitions of either cigarette user or ENDS/closed system user.
Agree to abide by the study restrictions.

Key exclusion criteria (17 listed)

Report receiving any investigational product, participated in any previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to screening.
Report at screening using both ENDS and conventional cigarettes (menthol or non-menthol) (dual users), or use of other inhaled products (such as, but not limited to cannabis) in the past 3 months.
For ENDS users, be unable to perform CPS or incapable of drawing down the pod weight by 20-60mg after 3 attempts at screening.
If female, be pregnant, have a positive urine pregnancy test at screening, be lactating, breast feeding, or intend to become pregnant during the time period from screening through the end of the study.
Have any clinically significant results from physical examinations and vital signs assessments, as judged by the Investigator.

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 5% Virginia TobaccoJUUL ENDS Virginia Tobacco 5% nicotine strength	Other	Group I
JUUL 3% Virginia Tobacco ENDSJUUL ENDS Virginia Tobacco 3% nicotine strength	Other	Group I
JUUL 5% Mint ENDSJUUL ENDS Mint 5% nicotine strength	Other	Group II
JUUL 3% Mint ENDSJUUL ENDS Mint 3% nicotine strength	Other	Group II
JUUL 5% Menthol ENDSJUUL ENDS Menthol 5% nicotine strength	Other	Group III
JUUL 3% Menthol ENDSJUUL ENDS Menthol 3% nicotine strength	Other	Group III
JUUL 5% Mango ENDSJUUL ENDS Mango 5% nicotine strength	Other	Group IV
JUUL 3% Mango ENDSJUUL ENDS Mango 3% nicotine strength	Other	Group IV
US Cigarette, Non-menthol - Marlboro Gold King SizeUS Cigarette, Non-menthol - Marlboro Gold King Size	Other	Group V
US Cigarette, Menthol - Newport King SizeUS Cigarette, Menthol - Newport King Size	Other	Group VI

Primary outcome

Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of nicotine for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of propylene glycol for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of vegetable glycerin for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of acetaldehyde for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of acrolein for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of benzoic acid for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of formaldehyde for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of menthol for each subject.
Evaluate Absolute Change from Baseline Level
Time frame: Up to 6-hours
The absolute change from baseline level of carbon monoxide for each subject.

10 secondary outcomes

Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Compare the change between baseline and post-baseline levels
Time frame: Up to 6-hours
Change in weight
Time frame: Up to 45

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 11 Feb 2020.
Derived from this study: PubMed 34544050Oldham MJ, Bailey PC, Castro N, Lang Q, Salehi A, Rostami AA. Prediction of potential passive exposure from commercial electronic nicotine delivery systems using exhaled breath analysis and computational fluid dynamic techniques. J Breath Res. 2021 Oct 5;15(4). doi: 10.1088/1752-7163/ac2884.
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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 inclusion and 17 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Evaluate Absolute Change from Baseline Level (time frame: Up to 6-hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143256, which also lists 1 linked publication.

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 11 Feb 2020.