Healthy VolunteersNCT04019626

A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

A study testing Continue-smoking, myblu Tobacco 2.5% and myblu Tobacco 4.0% in people with Healthy Volunteers, run by Fontem Ventures BV at 1 site 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

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Continue-smoking, myblu Tobacco 2.5% and myblu Tobacco 4.0%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2019to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Having smoked ≥5 manufactured combustible cigarettes per day for at least one year
Exhaled carbon monoxide level of >10 ppm at screening
Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Who cannot join

Relevant illness history
Relevant medication use
Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
Allergy to propylene glycol or glycerin
Use of nicotine-containing products other than manufactured cigarettes
Use of prescription smoking cessation treatments

Show all 9Show fewer

Smokers who draw smoke into their mouth and throat but do not inhale
Intent or desire to stop smoking
Female subjects who are pregnant, lactating, or intend to become pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Read the detailed description

Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially.

Conditions: Healthy Volunteers
Being tested: Continue-smoking, myblu Tobacco 2.5%, myblu Tobacco 4.0%, myblu Honeymoon 2.5%, myblu Honeymoon 4.0%

What participants receive

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

Continue-smokingOther
Ad-libitum use of subjects' usual brand combustible cigarette
myblu Tobacco 2.5%Other
Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
myblu Tobacco 4.0%Other
Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
myblu Honeymoon 2.5%Other
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
myblu Honeymoon 4.0%Other
Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
JUUL 5%Other
Ad-libitum use of JUUL 5% e-cigarette

Study groups in NCT04019626
Study group	Role	What they receive
Continue-smoking	Active comparator	The subject's usual brand of combustible cigarette Receives: Other: Continue-smoking
myblu Tobacco 2.5%	Experimental	myblu e-cigarette system with Tobacco flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant. Receives: Other: myblu Tobacco 2.5%
myblu Tobacco 4.0%	Experimental	myblu e-cigarette system with Tobacco flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant. Receives: Other: myblu Tobacco 4.0%
myblu Honeymoon 2.5%	Experimental	myblu e-cigarette system with Honeymoon flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant. Receives: Other: myblu Honeymoon 2.5%
myblu Honeymoon 4.0%	Experimental	myblu e-cigarette system with Honeymoon flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant. Receives: Other: myblu Honeymoon 4.0%
JUUL 5%	Active comparator	JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study. Receives: Other: JUUL 5%

What is being measured

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

Concentration of Carboxyhemoglobin in Blood
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Measured: Baseline and 56 days
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL - a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
Measured: Baseline and 56 days
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Measured: Baseline and 56 days
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours
Measured: Baseline and 56 days

Secondary outcomes (4)

Amount of Nicotine Equivalents in Urine in 24 Hours
The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
Measured: Baseline and 56 days
Level of White Blood Cells
The change from baseline in the level of white blood cells, which is a biomarker of potential harm
Measured: Baseline and 56 days
Subjective Measure: Nicotine Withdrawal Symptoms Total Score
Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
Measured: 56 days
Maximum Nicotine Concentration in Blood
The maximum nicotine concentration in blood (Cmax)
Measured: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose

Timeline

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

1 Mar 201931 Dec 2020

First posted15 Jul 2019
Study start1 Mar 2019
Primary completion31 Dec 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04019626
Sponsor's protocol ID: CA22747
Status last verified: Jun 2021
First submitted: 12 Jul 2019
Last updated: 30 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers
ClinicalTrials.gov ID: NCT04019626
Acronym / sponsor ID: CA22747
Conditions: Healthy Volunteers
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Fontem Ventures BVIndustry (pharma, biotech, devices)
Study start: 1 Mar 2019 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 15 Jul 2019 (actual)
Results: Posted 30 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Continue-smoking	Active comparator	Other: Continue-smokingThe subject's usual brand of combustible cigarette
myblu Tobacco 2.5%	Experimental	Other: myblu Tobacco 2.5%myblu e-cigarette system with Tobacco flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
myblu Tobacco 4.0%	Experimental	Other: myblu Tobacco 4.0%myblu e-cigarette system with Tobacco flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
myblu Honeymoon 2.5%	Experimental	Other: myblu Honeymoon 2.5%myblu e-cigarette system with Honeymoon flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
myblu Honeymoon 4.0%	Experimental	Other: myblu Honeymoon 4.0%myblu e-cigarette system with Honeymoon flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
JUUL 5%	Active comparator	Other: JUUL 5%JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.

Who may qualify

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

Key inclusion criteria (3 listed)

Having smoked ≥5 manufactured combustible cigarettes per day for at least one year
Exhaled carbon monoxide level of >10 ppm at screening
Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Key exclusion criteria (9 listed)

Relevant illness history
Relevant medication use
Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
Allergy to propylene glycol or glycerin
Use of nicotine-containing products other than manufactured cigarettes

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
Continue-smokingAd-libitum use of subjects' usual brand combustible cigarette	Other	Continue-smoking
myblu Tobacco 2.5%Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine	Other	myblu Tobacco 2.5%
myblu Tobacco 4.0%Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine	Other	myblu Tobacco 4.0%
myblu Honeymoon 2.5%Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine	Other	myblu Honeymoon 2.5%
myblu Honeymoon 4.0%Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine	Other	myblu Honeymoon 4.0%
JUUL 5%Ad-libitum use of JUUL 5% e-cigarette	Other	JUUL 5%

Primary outcome

Concentration of Carboxyhemoglobin in Blood
Time frame: Baseline and 56 days
Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
Time frame: Baseline and 56 days
Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL - a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
Time frame: Baseline and 56 days
Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA - a biomarker of exposure to acrolein) excreted in urine in 24-hours
Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
Time frame: Baseline and 56 days
Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA - a biomarker of exposure to benzene) excreted in urine in 24-hours

4 secondary outcomes

Amount of Nicotine Equivalents in Urine in 24 Hours
Time frame: Baseline and 56 days
Level of White Blood Cells
Time frame: Baseline and 56 days
Subjective Measure: Nicotine Withdrawal Symptoms Total Score
Time frame: 56 days
Maximum Nicotine Concentration in Blood
Time frame: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose

Results and safety

Results posted to the registry on 30 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Myblu Tobacco Flavor 2.5%	42	36
Myblu Tobacco Flavor 4.0%	42	32
Myblu Honeymoon 2.5%	45	37
Myblu Honeymoon 4.0%	46	39
Continue-smoking	44	38
JUUL 5%	21	20

Primary outcome: Concentration of Carboxyhemoglobin in Blood

Time frame: Baseline and 56 days. Mean (Standard Deviation). Unit: % change from baseline

Measure	Myblu Tobacco Flavor 2.5% n = 32	Myblu Tobacco Flavor 4.0% n = 49	Myblu Honeymoon 2.5% n = 24	Myblu Honeymoon 4.0% n = 33	Continue-smoking n = 37
Value	-59.6 (23.3)	-62.7 (19.4)	-46.4 (35.1)	-62.7 (21.2)	8.5 (28.3)

Population analysed: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (cf "Study Description"). Therefore, the number of subjects analysed in one arm may be different from the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study

Primary outcome: Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours

Time frame: Baseline and 56 days. Mean (Standard Deviation). Unit: % change from baseline

Measure	Myblu Tobacco Flavor 2.5% n = 32	Myblu Tobacco Flavor 4.0% n = 52	Myblu Honeymoon 2.5% n = 25	Myblu Honeymoon 4.0% n = 35	Continue-smoking n = 38
Value	-58.3 (72.8)	-44.7 (150.5)	-62.7 (36.2)	-70.7 (33.7)	1.1 (29.6)

Population analysed: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study

Primary outcome: Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours

Time frame: Baseline and 56 days. Mean (Standard Deviation). Unit: % change from baseline

Measure	Myblu Tobacco Flavor 2.5% n = 32	Myblu Tobacco Flavor 4.0% n = 52	Myblu Honeymoon 2.5% n = 25	Myblu Honeymoon 4.0% n = 35	Continue-smoking n = 38
Value	-60.0 (28.2)	-55.7 (46.1)	-50.5 (36.2)	-53.8 (64.5)	1.6 (40.6)

Population analysed: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study

Primary outcome: Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours

Time frame: Baseline and 56 days. Mean (Standard Deviation). Unit: % change from baseline

Measure	Myblu Tobacco Flavor 2.5% n = 32	Myblu Tobacco Flavor 4.0% n = 52	Myblu Honeymoon 2.5% n = 25	Myblu Honeymoon 4.0% n = 35	Continue-smoking n = 38
Value	-85.9 (32.5)	-44.9 (257.5)	-63.1 (79.3)	-73.8 (55.7)	-2.7 (38.4)

Population analysed: Available data from the Intent-to-treat population (ITT; randomized subjects in the main study with at least one documented product-use experience from Day 1) is presented. Subjects using the myblu e-cigarette were allowed to switch product variant in the course of the study (see "Study Description"). Therefore, the number of subjects analysed in one arm may be different than the number of subjects who were initially assigned to this product at the study start. JUUL arm was only for PK sub-study

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 72 days (58 study days plus 14 follow-up days) for all arms except JUUL. 15 day for JUUL arm.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Myblu Tobacco Flavor 2.5%	0 of 55 (0%)	8 of 55 (14.5%)	0 of 55
Myblu Tobacco Flavor 4.0%	0 of 71 (0%)	10 of 71 (14.1%)	0 of 71
Myblu Honeymoon 2.5%	0 of 47 (0%)	6 of 47 (12.8%)	0 of 47
Myblu Honeymoon 4.0%	0 of 57 (0%)	6 of 57 (10.5%)	0 of 57
Continue-smoking	0 of 44 (0%)	7 of 44 (15.9%)	0 of 44
JUUL® 5.0%	0 of 21 (0%)	8 of 21 (38.1%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Continue-smoking, myblu Tobacco 2.5% and myblu Tobacco 4.0% in people with Healthy Volunteers, run by Fontem Ventures BV at 1 site 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 3 inclusion and 9 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 30 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 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?

Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Concentration of Carboxyhemoglobin in Blood (time frame: Baseline and 56 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 NCT04019626.

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 30 Jun 2021.