Nicotine DependenceNCT03593239

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

A study testing Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS and Mint flavored JUUL 1.7% ENDS in people with Nicotine Dependence and Nicotine Dependence, Cigarettes, run by Juul Labs, Inc. at 1 site in New Zealand.

Completed

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

Official record

Search all trials

Trial summary

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use
What is being tested?: Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS and Mint flavored JUUL 1.7% ENDS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteNew Zealand
Study dates: 29 Jun 2018to 26 Jul 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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female aged 18 to 60 years of age inclusive.
Current smoker or e-cigarette user:
Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Who cannot join

Clinically significant abnormality on screening ECG.
Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
Positive result for urine drugs of abuse test or alcohol breath test at screening.
Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
Any clinically significant concomitant disease or conditions.

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

Christchurch Clinical Studies Trust Ltd
Christchurch, 8011

Other trials in New Zealand

About this study

Official title: A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), in Healthy Adult Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Read the detailed description

E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Conditions: Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
Being tested: Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS, Mint flavored JUUL 1.7% ENDS, Mint flavored JUUL 5% ENDS, Fruit Medley flavored JUUL 1.7% ENDS
Keywords: Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Medical subject headings: Tobacco Use Disorder, Tobacco Use, Tobacco Smoking, Vaping

What participants receive

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

Tobacco flavored JUUL 1.7% ENDSOther
Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)
Tobacco flavored JUUL 5% ENDSOther
Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)
Mint flavored JUUL 1.7% ENDSOther
Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)
Mint flavored JUUL 5% ENDSOther
Treatment with Mint flavored JUUL 5% ENDS(10 puffs)
Fruit Medley flavored JUUL 1.7% ENDSOther
Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)
Fruit Medley flavored JUUL 5% ENDSOther
Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)
Crème brulee flavored JUUL 1.7% ENDSOther
Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)
Crème brulee flavored JUUL 5% ENDSOther
Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)
JUUL 1.7% ENDS 10 puffs vs. ad lib puffsOther
Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffsOther
Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

Study groups in NCT03593239
Study group	Role	What they receive
Tobacco flavored JUUL 1.7% ENDS	Experimental	Tobacco flavored JUUL 1.7% ENDS (10 puffs) Receives: Other: Tobacco flavored JUUL 1.7% ENDS
Tobacco flavored JUUL 5% ENDS	Experimental	Tobacco flavored JUUL 5% ENDS (10 puffs) Receives: Other: Tobacco flavored JUUL 5% ENDS
Mint flavored JUUL 1.7% ENDS	Experimental	Mint flavored JUUL 1.7% ENDS (10 puffs); Receives: Other: Mint flavored JUUL 1.7% ENDS
Mint flavored JUUL 5% ENDS	Experimental	Mint flavored JUUL 5% ENDS (10 puffs) Receives: Other: Mint flavored JUUL 5% ENDS
Fruit Medley flavored JUUL 1.7% ENDS	Experimental	Fruit Medley flavored JUUL 1.7% ENDS (10 puffs) Receives: Other: Fruit Medley flavored JUUL 1.7% ENDS
Fruit Medley flavored JUUL 5% ENDS	Experimental	Fruit Medley flavored JUUL 5% ENDS (10 puffs) Receives: Other: Fruit Medley flavored JUUL 5% ENDS
Crème brulee flavored JUUL 1.7% ENDS	Experimental	Crème brulee flavored JUUL 1.7% ENDS (10 puffs) Receives: Other: Crème brulee flavored JUUL 1.7% ENDS
Crème brulee flavored JUUL 5% ENDS	Experimental	Crème brulee flavored JUUL 5% ENDS (10 puffs) Receives: Other: Crème brulee flavored JUUL 5% ENDS
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs	Experimental	Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs Receives: Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffs	Experimental	Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs Receives: Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs

What is being measured

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

Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with:
Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Measured: 38 Days
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with:
Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Measured: 38 Days
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with:
Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Measured: 38 Days
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with:
Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Measured: 38 Days

Secondary outcomes (2)

Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Measured: 38 Days
To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.
Measure of subjective product evaluation using the "modified Product Evaluation Scale (mPES)" Change in Evaluation; Scale: 1 = not at all, 2 = very little, 3 = a little, 4 = moderately, 5 = a lot, 6 = quite a lot, 7 = extremely
Four multi-item subscales will be derived from "Satisfaction" (items 1, 2, 3, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9, 10, 16, and 18); and "Relief" (item 11, 13, 14, 15, and reversed for item 19) and single items 17 and 20 will be summarized.
Measured: 38 Days

Timeline

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

29 Jun 201826 Jul 2018

First posted20 Jul 2018
Study start29 Jun 2018
Primary completion26 Jul 2018
Study completion26 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nicotine DependenceStudies 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
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03593239
Sponsor's protocol ID: PROT-00008 / v2.1
Status last verified: Jun 2021
First submitted: 1 Jun 2018
Last updated: 21 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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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All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), in Healthy Adult Smokers
ClinicalTrials.gov ID: NCT03593239
Acronym / sponsor ID: PROT-00008 / v2.1
Conditions: Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
Keywords: Electronic Nicotine Delivery System, Combustible Cigarettes, Nicotine
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Juul Labs, Inc.Industry (pharma, biotech, devices)
Study start: 29 Jun 2018 (actual)
Primary completion: 26 Jul 2018 (actual)
Study completion: 26 Jul 2018 (actual)
First posted: 20 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 Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
Tobacco flavored JUUL 1.7% ENDS	Experimental	Other: Tobacco flavored JUUL 1.7% ENDSTobacco flavored JUUL 1.7% ENDS (10 puffs)
Tobacco flavored JUUL 5% ENDS	Experimental	Other: Tobacco flavored JUUL 5% ENDSTobacco flavored JUUL 5% ENDS (10 puffs)
Mint flavored JUUL 1.7% ENDS	Experimental	Other: Mint flavored JUUL 1.7% ENDSMint flavored JUUL 1.7% ENDS (10 puffs);
Mint flavored JUUL 5% ENDS	Experimental	Other: Mint flavored JUUL 5% ENDSMint flavored JUUL 5% ENDS (10 puffs)
Fruit Medley flavored JUUL 1.7% ENDS	Experimental	Other: Fruit Medley flavored JUUL 1.7% ENDSFruit Medley flavored JUUL 1.7% ENDS (10 puffs)
Fruit Medley flavored JUUL 5% ENDS	Experimental	Other: Fruit Medley flavored JUUL 5% ENDSFruit Medley flavored JUUL 5% ENDS (10 puffs)
Crème brulee flavored JUUL 1.7% ENDS	Experimental	Other: Crème brulee flavored JUUL 1.7% ENDSCrème brulee flavored JUUL 1.7% ENDS (10 puffs)
Crème brulee flavored JUUL 5% ENDS	Experimental	Other: Crème brulee flavored JUUL 5% ENDSCrème brulee flavored JUUL 5% ENDS (10 puffs)
JUUL 1.7% ENDS 10 puffs vs. ad lib puffs	Experimental	Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffsTobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffs	Experimental	Other: JUUL 5% ENDS 10 puffs vs. ad lib puffsTobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female aged 18 to 60 years of age inclusive.
Current smoker or e-cigarette user:
Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Key exclusion criteria (7 listed)

Clinically significant abnormality on screening ECG.
Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
Positive result for urine drugs of abuse test or alcohol breath test at screening.
Clinically significant abnormality in laboratory test results at screening, in the opinion of 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
Tobacco flavored JUUL 1.7% ENDSTreatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)	Other	Tobacco flavored JUUL 1.7% ENDS
Tobacco flavored JUUL 5% ENDSTreatment with Tobacco flavored JUUL 5% ENDS(10 puffs)	Other	Tobacco flavored JUUL 5% ENDS
Mint flavored JUUL 1.7% ENDSTreatment with Mint flavored JUUL 1.7% ENDS(10 puffs)	Other	Mint flavored JUUL 1.7% ENDS
Mint flavored JUUL 5% ENDSTreatment with Mint flavored JUUL 5% ENDS(10 puffs)	Other	Mint flavored JUUL 5% ENDS
Fruit Medley flavored JUUL 1.7% ENDSTreatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)	Other	Fruit Medley flavored JUUL 1.7% ENDS
Fruit Medley flavored JUUL 5% ENDSTreatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)	Other	Fruit Medley flavored JUUL 5% ENDS
Crème brulee flavored JUUL 1.7% ENDSTreatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)	Other	Crème brulee flavored JUUL 1.7% ENDS
Crème brulee flavored JUUL 5% ENDSTreatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)	Other	Crème brulee flavored JUUL 5% ENDS
JUUL 1.7% ENDS 10 puffs vs. ad lib puffsTreatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs	Other	JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffsTreatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs	Other	JUUL 5% ENDS 10 puffs vs. ad lib puffs

Primary outcome

Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)
Time frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)
Time frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour
Time frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).
Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine
Time frame: 38 Days
Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).

2 secondary outcomes

Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.
Time frame: 38 Days
To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.
Time frame: 38 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 21 Jun 2021.
Individual participant dataSharing planned: No

Related trials for Nicotine Dependence

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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.

Christopher Wynne, MD principal investigator

Christchurch Clinical Studies Trust Ltd

1 site 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 3 inclusion and 7 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 21 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 1 site in New Zealand. 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?

Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax) (time frame: 38 Days). The study lists 4 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 NCT03593239.

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 21 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.