E-cigarette UseNCT05072925

BIDI Stick ENDS Abuse Liability and Puffing Topography Assessment

A study testing Tobacco products in people with E-cigarette Use and Cigarette Smoking, run by BIDI Vapor at 1 site in Poland.

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

This study assessed the abuse liability (measured by assessing how much nicotine enters the body when the BIDI Stick is used, and how this makes users feel) and puffing topography (puff characteristics like volume and duration) of the BIDI Stick ENDS, a type of electronic cigarette. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: E-cigarette Use, Cigarette Smoking
What is being tested?: Tobacco products
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 sitePoland
Study dates: 7 Jul 2021to 23 Jul 2021
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 males or females within the ages of 21 to 65 years, inclusive.
Subjects will have a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive, and a body weight exceeding 52 kg (males) or 45 kg (females).
Subjects must be current smokers (≥10 per day) of factory-made, high tar (10mg) combustible cigarettes (eCO >10 ppm at screening) for at least one continuous year before Visit 1 and may be occasional or dual users of e-cigarettes.
Urine cotinine >200 ng/mL.
Subject demonstrates understanding of the study and willingness/consent to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the consent form.
Subject understands and is willing, able, and likely to comply with all the study procedures and restrictions.

Show all 9Show fewer

Subject is in good general health in the opinion of the investigator, with no clinically significant and relevant abnormalities of medical history (e.g., uncontrolled hypertension, recent myocardial infarction or unstable angina, history of seizures or recent stomach ulcer).
Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure ≤95 mmHg, and heart rate ≤100 bpm.
Females of childbearing potential are, in the opinion of the investigator, practicing a reliable method of contraception.

Who cannot join

Subjects who, in the judgment of the study physician, have recent or active COVID 19 infection, as evidenced by the following:
Endorsement of symptoms that could indicate COVID-19 during screening (Section 13.1) and/or
Body temperature ≥38.0°C and/or
Laboratory test results suggestive of active or recent exposure to SARS-CoV-2 (Section 9.4).
Laboratory serology results positive for HBsAg, hepatitis C virus (HCV) antibody, (HIV) type 1 or 2.
Subjects who have participated in another clinical study within 30 days of Visit 1 or who have previously participated in this study.

Show all 25Show fewer

Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection) requiring treatment in the 4 weeks prior to Visit 1, or an active respiratory infection at time of the Screening Visit.
Subject has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, lung x-ray or clinical laboratory results that could interfere with, or for which use of the study products might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Subjects who have used any nicotine or tobacco product other than e-cigarettes or factory-made combustible cigarettes in the 14 days prior to the Visit 1.
Subjects who are self-reported or observed (during the trial session at Visit 2) non inhalers during ENDS/cigarette use.
Subjects who have used any prescription or over-the-counter (OTC) smoking cessation treatments, including, but not limited to any form of nicotine replacement therapy (NRT), varenicline, cytisine, or bupropion within 30 days prior to Visit 1.
Is planning to quit smoking during the study or postponing a quit attempt in order to participate in the study.
Subjects who have used prescription or OTC bronchodilator medication (e.g., inhaled or oral β adrenergic agonists, anticholinergics, glucocorticoids, cromones, or theophylline) to treat a chronic condition within the 12 months prior to Visit 1 or have a history of lung disease.
Subjects who have received any medications or substances that interfere with the cyclooxygenase pathway within 14 days prior to Visit 1 or are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half lives of the drug (whichever is longer) prior to Visit 1.
Women who are pregnant or who have a positive urine pregnancy test.
Women who are breast-feeding.
Subject has a history or diagnosis of adult asthma, COPD (including emphysema and chronic bronchitis), or use of an inhaler within the past 3 months.
Subject has been hospitalized in the 28 days prior to the Visit 1.
Subject has a history of schizophrenia, psychosis, or bipolar disorder.
Subject provides a positive drugs of abuse urine test at Visit 1. Tested drugs will include cocaine, amphetamines, methamphetamines, opiates (morphine, heroin), barbiturates, and benzodiazepine.
Subject has a self-reported use of more than 21 drinks per week. A drink is defined as 25 ml of spirits (e.g., whisky, vodka), 250 ml of beer, or 75 ml of wine.
Subjects who have lost or donated more than 450 mL of blood within the 2 months preceding the first product use.
Subject is an employee of the sponsor or the study site, or members of their immediate family.
In the opinion of the investigator, the subject should not participate in this study.
A history of allergy/oversensitivity to the ingredients of the study products.

Trial locations and contacts

1 site in 1 country.

Poland1 site

MTZ Clinical Research Sp. z o.o.
Warsaw, 02-106

Other trials in Poland

About this study

Official title: Abuse Liability and Puffing Topography Assessments of the BIDI Stick Electronic Nicotine Delivery System (ENDS) in Comparison to a Combustible Cigarette and JUUL Pod-Based ENDS

Read the detailed description

This is a part-randomized, open label abuse liability assessment (ALA) and puffing topography study of nicotine-containing products carried out in 18 healthy adult volunteers who smoke combustible cigarettes.

Subjects will attend the study site 8 times (Visits 2-9) during the main study for ALA and puff topography assessments. Prior to each visit, subjects will be required to refrain from using any nicotine-containing products for a period of at least 12 hours before study product use.

At Visit 2, the subjects will smoke their usual brand cigarette during 2 use sessions. In the first session, subjects will smoke a single combustible cigarette of their usual brand by taking 10 puffs, 30 seconds apart. Blood samples will be obtained for plasma nicotine analysis, and blood pressure and heart rate will be recorded. Subjects will be asked to complete subjective effects questionnaires at various points either before, during, or after product use.

In the second session, which will begin immediately after the last blood draw following the first session and after all questionnaires have been completed, subjects will be allowed to take ad libitum puffs on their usual brand cigarette for a period of 60 minutes (1 hour). In a randomly-selected subset of 8 subjects, during this ad libitum puffing session puffing topography measurements will be made with a CReSS Pocket device. Subjects may smoke as many cigarettes as they like. In all subjects, a blood sample for nicotine PK analysis will be drawn at the end of the session. Blood pressure and heart rate will be recorded at this time. Subjective effects questionnaires will also be completed at specified timepoints.

At Visits 3-9, the subjects will use their randomly-assigned ENDS product during 2 use sessions. These use sessions, and the assessments made, will be the same as at visit 2. Prior to visit 3-9, subjects will be provided with a supply of their randomly-assigned product to use at home before their next visit (familiarization). This familiarization period should last a minimum of 2 and a maximum of 5 days.

Conditions: E-cigarette Use, Cigarette Smoking
Being tested: Tobacco products
Medical subject headings: Vaping, Cigarette Smoking

What participants receive

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

Tobacco productsOther
Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions

Study groups in NCT05072925
Study group	Role	What they receive
Combustible Cigarette	Active comparator	The usual brand of combustible cigarette smoked by study subjects, with a minimum Federal Trade Commission tar yield of 8mg Receives: Other: Tobacco products
BIDI Stick ENDS Arctic flavor	Experimental	BIDI Stick ENDS containing 6% nicotine and Arctic flavor Receives: Other: Tobacco products
BIDI Stick ENDS Classic flavor	Experimental	BIDI Stick ENDS containing 6% nicotine and Classic flavor Receives: Other: Tobacco products
BIDI Stick ENDS Zest flavor	Experimental	BIDI Stick ENDS containing 6% nicotine and Zest flavor Receives: Other: Tobacco products
BIDI Stick ENDS Regal flavour	Experimental	BIDI Stick ENDS containing 6% nicotine and Regal flavor Receives: Other: Tobacco products
BIDI Stick ENDS Winter flavour	Experimental	BIDI Stick ENDS containing 6% nicotine and Winter flavor Receives: Other: Tobacco products
BIDI Stick ENDS Solar flavor	Experimental	BIDI Stick ENDS containing 6% nicotine and Solar flavor Receives: Other: Tobacco products
JUUL ENDS Virginia Tobacco flavor	Active comparator	JUUL ENDS containing 5% nicotine and Virginia Tobacco flavor Receives: Other: Tobacco products

What is being measured

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

Baseline-adjusted plasma nicotine Cmax0-120
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 120 minutes after the start of product use
Measured: 0-120 minutes
Baseline-adjusted plasma nicotine Tmax0-120
Baseline-adjusted plasma nicotine Tmax following defined product use
Measured: 0-120 minutes
Baseline-adjusted plasma nicotine AUC0-120
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 120 minutes after the start of product use
Measured: 0-120 minutes
Baseline-adjusted plasma nicotine Cmax0-180
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 180 minutes after the start of product use
Measured: 0-180 minutes
Baseline-adjusted plasma nicotine Tmax0-180
Baseline-adjusted plasma nicotine Tmax following both defined and ad libitum product use
Measured: 0-180 minutes
Baseline-adjusted plasma nicotine AUC0-180
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 180 minutes after the start of product use
Measured: 0-180 minutes
Product liking
Visual analog scale product liking assessment; scale from 0 to 100 with higher scores representing stronger liking.
Measured: 180 minutes
Intent to Use Product Again
Visual analog scale intent to use product again assessment; scale from 0 to 100 with higher scores representing stronger intent to use the product again.
Measured: 180 minutes
Urge to Smoke
Visual analog scale urge to smoke assessment; scale from 0 to 100 with higher scores representing stronger urge to smoke.
Measured: 0-180 minutes
Product Evaluation Scale
Subjective effects assessment using Product Evaluation Scale, which included 21 items with responses recorded on a scale of 1 to 7 ranging from 'Not at all' to 'Extremely'.
Measured: 180 minutes
Mass change
Mass change in grams of ENDS products during use sessions
Measured: 0-5 minutes and 120-180 minutes

Secondary outcomes (5)

Puff duration
Puff duration from puffing topography measurements
Measured: 120-180 minutes
Puff volume
Puff volume from puffing topography measurements
Measured: 120-180 minutes
Peak puff flow rate
Peak puff flow rate from puffing topography measurements
Measured: 120-180 minutes
Average puff flow rate
Average puff flow rate from puffing topography measurements
Measured: 120-180 minutes
Inter-puff interval
Time between puffs from puffing topography measurements
Measured: 120-180 minutes

Timeline

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

7 Jul 202123 Jul 2021

First posted11 Oct 2021
Study start7 Jul 2021
Primary completion23 Jul 2021
Study completion23 Jul 2021

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 E-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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05072925
Sponsor's protocol ID: BIDI-PK-01
Status last verified: Oct 2021
First submitted: 26 Sep 2021
Last updated: 11 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fearon IM, Gilligan K, Seltzer RGN, McKinney W. A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI(R) stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers. Harm Reduct J. 2022 Jun 2;19(1):57. doi: 10.1186/s12954-022-00638-0.
PubMed 35655314

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 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Abuse Liability and Puffing Topography Assessments of the BIDI Stick Electronic Nicotine Delivery System (ENDS) in Comparison to a Combustible Cigarette and JUUL Pod-Based ENDS
ClinicalTrials.gov ID: NCT05072925
Acronym / sponsor ID: BIDI-PK-01
Conditions: E-cigarette Use, Cigarette Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: BIDI VaporIndustry (pharma, biotech, devices)
Study start: 7 Jul 2021 (actual)
Primary completion: 23 Jul 2021 (actual)
Study completion: 23 Jul 2021 (actual)
First posted: 11 Oct 2021 (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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Combustible Cigarette	Active comparator	Other: Tobacco productsThe usual brand of combustible cigarette smoked by study subjects, with a minimum Federal Trade Commission tar yield of 8mg
BIDI Stick ENDS Arctic flavor	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Arctic flavor
BIDI Stick ENDS Classic flavor	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Classic flavor
BIDI Stick ENDS Zest flavor	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Zest flavor
BIDI Stick ENDS Regal flavour	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Regal flavor
BIDI Stick ENDS Winter flavour	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Winter flavor
BIDI Stick ENDS Solar flavor	Experimental	Other: Tobacco productsBIDI Stick ENDS containing 6% nicotine and Solar flavor
JUUL ENDS Virginia Tobacco flavor	Active comparator	Other: Tobacco productsJUUL ENDS containing 5% nicotine and Virginia Tobacco flavor

Who may qualify

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

Key inclusion criteria (9 listed)

Healthy males or females within the ages of 21 to 65 years, inclusive.
Subjects will have a body mass index (BMI) of 18.5 to 35.0 kg/m2, inclusive, and a body weight exceeding 52 kg (males) or 45 kg (females).
Subjects must be current smokers (≥10 per day) of factory-made, high tar (10mg) combustible cigarettes (eCO >10 ppm at screening) for at least one continuous year before Visit 1 and may be occasional or dual users of e-cigarettes.
Urine cotinine >200 ng/mL.
Subject demonstrates understanding of the study and willingness/consent to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the consent form.

Key exclusion criteria (25 listed)

Subjects who, in the judgment of the study physician, have recent or active COVID 19 infection, as evidenced by the following:
Laboratory serology results positive for HBsAg, hepatitis C virus (HCV) antibody, (HIV) type 1 or 2.
Subjects who have participated in another clinical study within 30 days of Visit 1 or who have previously participated in this study.
Subjects who have an acute illness (e.g., upper respiratory tract infection, viral infection) requiring treatment in the 4 weeks prior to Visit 1, or an active respiratory infection at time of the Screening Visit.
Subject has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, lung x-ray or clinical laboratory results that could interfere with, or for which use of the study products might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this 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
Tobacco productsProducts will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions	Other	BIDI Stick ENDS Arctic flavor, BIDI Stick ENDS Classic flavor, BIDI Stick ENDS Regal flavour, BIDI Stick ENDS Solar flavor, BIDI Stick ENDS Winter flavour, BIDI Stick ENDS Zest flavor, Combustible Cigarette, JUUL ENDS Virginia Tobacco flavor

Primary outcome

Baseline-adjusted plasma nicotine Cmax0-120
Time frame: 0-120 minutes
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 120 minutes after the start of product use
Baseline-adjusted plasma nicotine Tmax0-120
Time frame: 0-120 minutes
Baseline-adjusted plasma nicotine Tmax following defined product use
Baseline-adjusted plasma nicotine AUC0-120
Time frame: 0-120 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 120 minutes after the start of product use
Baseline-adjusted plasma nicotine Cmax0-180
Time frame: 0-180 minutes
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 180 minutes after the start of product use
Baseline-adjusted plasma nicotine Tmax0-180
Time frame: 0-180 minutes
Baseline-adjusted plasma nicotine Tmax following both defined and ad libitum product use
Baseline-adjusted plasma nicotine AUC0-180
Time frame: 0-180 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 180 minutes after the start of product use
Product liking
Time frame: 180 minutes
Visual analog scale product liking assessment; scale from 0 to 100 with higher scores representing stronger liking.
Intent to Use Product Again
Time frame: 180 minutes
Visual analog scale intent to use product again assessment; scale from 0 to 100 with higher scores representing stronger intent to use the product again.
Urge to Smoke
Time frame: 0-180 minutes
Visual analog scale urge to smoke assessment; scale from 0 to 100 with higher scores representing stronger urge to smoke.
Product Evaluation Scale
Time frame: 180 minutes
Subjective effects assessment using Product Evaluation Scale, which included 21 items with responses recorded on a scale of 1 to 7 ranging from 'Not at all' to 'Extremely'.
Mass change
Time frame: 0-5 minutes and 120-180 minutes
Mass change in grams of ENDS products during use sessions

5 secondary outcomes

Puff duration
Time frame: 120-180 minutes
Puff volume
Time frame: 120-180 minutes
Peak puff flow rate
Time frame: 120-180 minutes
Average puff flow rate
Time frame: 120-180 minutes
Inter-puff interval
Time frame: 120-180 minutes

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 Oct 2021.
Derived from this study: PubMed 35655314Fearon IM, Gilligan K, Seltzer RGN, McKinney W. A randomised, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the BIDI(R) stick ENDS compared with combustible cigarettes and a comparator ENDS in adult smokers. Harm Reduct J. 2022 Jun 2;19(1):57. doi: 10.1186/s12954-022-00638-0.
Individual participant dataSharing planned: No

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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.

Anna O Popko, MD principal investigator

MTZ Clinical Research Sp z.o.o.

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

Questions about this trial

What is this clinical trial studying?

A study testing Tobacco products in people with E-cigarette Use and Cigarette Smoking, run by BIDI Vapor at 1 site in Poland.

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 9 inclusion and 25 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 Oct 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 Poland. 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?

Baseline-adjusted plasma nicotine Cmax0-120 (time frame: 0-120 minutes). The study lists 11 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 NCT05072925, 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 Oct 2021.