Electronic Cigarette UseNCT04620616

Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by ENDS Consumers

A study testing RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor and Subject Usual Brand ENDS in people with Electronic Cigarette Use, run by Cheerain HK Limited at 2 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

This study is being conducted to evaluate nicotine uptake, the potential abuse liability, and puffing topography associated with the use of an electronic nicotine delivery system (ENDS) with tobacco- and menthol-flavored e-liquids in current ENDS consumers. Read more about this study

Who is it for?: Ages 22 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Electronic Cigarette Use
What is being tested?: RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor and Subject Usual Brand ENDS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesUnited States
Study dates: 11 Sep 2020to 14 Jan 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 22 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
Is 22 to 59 years of age, inclusive, at the time of consent.
Has been a daily ENDS consumer for at least 3 months prior to Screening and through Check-in. Brief periods of abstinence (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where vaping was prohibited) ≥ 30 days prior to Screening will be permitted at the discretion of an Investigator.
Reports weekly use of at least 3 mL of e-liquid from an ENDS product at Screening.
Has a urine cotinine concentration ≥ of 200 ng/mL at Screening and Check-in.
Has an exhaled carbon monoxide (ECO) concentration < 10 ppm at Check-in.

Show all 10Show fewer

If female, must meet one of the following criteria:
If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first product use, during the study, and for at least 30 days after the last product use. An acceptable method of contraception includes one of the following: abstinence from heterosexual intercourse, hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch), intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) during the study and for at least 30 days after the last product use.
If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (≥ 40 mIU/mL).
Is willing to comply with the requirements of the study.

Who cannot join

Has a history or presence of clinically significant uncontrolled gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that would jeopardize the safety of the subject or impact the validity of the study results.
Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results.
Has a positive test for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen, or Hepatitis C Antibody.
Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Check-in.
Has a fever (> 100.5°F) at Screening or Check-in.
Has a positive COVID-19 test during the screening period, prior to Check-in.

Show all 30Show fewer

Has a body mass index greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
Has a history of drug or alcohol abuse within 12 months of Screening.
Has a systolic BP < 90 mmHg or > 150 mmHg, diastolic BP < 40 mmHg or > 95 mmHg, or HR < 40 bpm or > 99 bpm at Screening.
Is allergic to or intolerant of components of the product e-liquid, including but not limited to, menthol, propylene glycol or glycerin.
Is unable to use the CReSS topography device with the vaping device during the training session on Day -1.
Has an estimated creatinine clearance < 70 mL/minute (using the Cockcroft Gault equation) at Screening.
Has a positive urine drug or alcohol test at Screening or Check-in. A positive test result for cannabinoids may be permitted if the result to the cannabis intoxication evaluation is negative at Check-in.
If female, has a positive pregnancy test, is breastfeeding or lactating, or intends to become pregnant from Screening through Day 5.
Has been treated for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months of Check-in.
Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected.
Has used medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within 6 weeks prior to Check-in.
Has used a product containing pseudoephedrine within 48 hours prior to Check-in.
Has used any other tobacco- or nicotine-containing products other than closed-system ENDS products (e.g., open-system ENDS, cigarettes, cigars, pipes, snuff, pouches, chewing tobacco, nicotine inhalers, nicotine patches, nicotine sprays, nicotine lozenges, or nicotine gum) within 7 days of Check-in.
Has used any products for the purpose of smoking/vaping cessation, including, but not limited to, nicotine replacement therapies, varenicline (Chantix), or bupropion (Zyban) from 30 days prior to Screening through Check-in.
Is a self-reported puffer (i.e., draws aerosol from the ENDS into the mouth and throat but does not inhale).
Is postponing a planned vaping quit attempt in order to participate in the study.
Has donated plasma within 7 days prior to Check-in.
Has provided a whole blood donation, had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Check-in.
Has participated in a previous clinical study for a tobacco product or an investigational drug, device, or biologic, within 30 days or 5 times the half-life of the product (whichever is longer) prior to Check-in.
Is or has a first-degree relative (e.g., spouse, parent, sibling, child) who is a current or former employee of a tobacco or ENDS manufacturer or is a named party or class representative in litigation with the tobacco or ENDS industry.
Is or has a first-degree relative (e.g., spouse, parent, sibling, child) who is a current employee of the clinic site(s).
Is or has a first-degree relative (e.g., spouse, parent, sibling, child) who is a current employee of the Sponsor.
Has previously been withdrawn from or has completed this study.
In the opinion of an Investigator, the subject should not participate in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

WCCT Global, Inc
Cypress, California, 90630
Altasciences Clinical Kansas, Inc
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Multi-Center, Cross-Over Study of Adult Electronic Nicotine Delivery Systems (ENDS) Consumers to Assess Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With RELX Infinity ENDS

Conditions: Electronic Cigarette Use
Being tested: RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor, Subject Usual Brand ENDS
Keywords: Electronic Nicotine Delivery System, Nicotine, Pharmacokinetics, Abuse Liability, Topography, E-cigarette
Medical subject headings: Vaping

What participants receive

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

RELX ENDS Tobacco FlavorOther
Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
RELX ENDS Menthol FlavorOther
Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
Subject Usual Brand ENDSOther
Ad libitum use of the usual brand product during 8-hour and 5-minute use sessions

Study groups in NCT04620616
Study group	Role	What they receive
Product Use Sequence 1	Experimental	Products use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - RELX ENDS menthol flavor Period 3 - Usual Brand ENDS Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS
Product Use Sequence 2	Experimental	Products use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS tobacco flavor Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS
Product Use Sequence 3	Experimental	Products use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS tobacco flavor Period 3 - RELX ENDS menthol flavor Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS
Product Use Sequence 4	Experimental	Products use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS menthol flavor Period 3 - RELX ENDS tobacco flavor Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS
Product Use Sequence 5	Experimental	Products use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS menthol flavor Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS
Product Use Sequence 6	Experimental	Products use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - RELX ENDS tobacco flavor Period 3 - Usual Brand ENDS Receives: Other: RELX ENDS Tobacco Flavor; Other: RELX ENDS Menthol Flavor; Other: Subject Usual Brand ENDS

What is being measured

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

Nicotine uptake
PK Session baseline-adjusted maximum plasma nicotine concentration [Cmax]
Measured: 120 minutes
Nicotine uptake
PK Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-120)]
Measured: 120 minutes

Secondary outcomes (22)

Nicotine uptake - PK Session
PK Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-15)]
Measured: 15 minutes
Nicotine uptake - PK Session
PK Session time of the maximum post-baseline nicotine concentration [Tmax]
Measured: 120 minutes
Nicotine uptake - Ad Libitum Session
Ad Libitum Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-480)]
Measured: 480 minutes
Subject effects as measured by the Modified Product Evaluation Scale
Subjective product assessments during the Ad Libitum Session as measured by responses to the Modified Product Evaluation Scale (scale range of 1 [not at all] to 7 [extremely])
Measured: 480 minutes
Subject effects as measured by the Future Intent to Use questionnaire
Subjective product assessments during the Ad Libitum Session as measured by responses to the Future Intent to Use questionnaire (visual analog scale range of "Definitely Would Not" to "Definitely Would")
Measured: 480 minutes
Subject effects as measured by the Urge to Vape questionnaire
Subjective product assessments during the PK Session as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Measured: 120 minutes
Subject effects as measured by the Product Liking questionnaire
Subjective product assessments during the PK Session as measured by responses to the Product Liking questionnaire (visual analog scale range of "Not at All" to "Extremely")
Measured: 120 minutes
Physiologic effects as measured by heart rate
Heart rate measurements during the Ad Libitum Session
Measured: 480 minutes
Physiologic effects as measured by heart rate
Heart rate measurements during the PK Session
Measured: 120 minutes
Physiologic effects as measured by blood pressure
Blood pressure measurements during the Ad Libitum Session
Measured: 480 minutes
Physiologic effects as measured by blood pressure
Blood pressure measurements during the PK Session
Measured: 120 minutes
Study product use
Change in weight of study products during the Ad Libitum Session
Measured: 480 minutes
Study product use
Number of requests to use the study products during the Ad Libitum Session
Measured: 480 minutes
Study product use
Number of puffs taken from the study products during the Ad Libitum Session topography assessment
Measured: 60 minutes
Study product use
Duration of puffs taken from the study products during the Ad Libitum Session topography assessment
Measured: 60 minutes
Study product use
Volume of puffs taken from the study products during the Ad Libitum Session topography assessment
Measured: 60 minutes
Study product use
Flow rate of puffs taken from the study products during the Ad Libitum Session topography assessment
Measured: 60 minutes
Study product use
Inter-puff interval of puffs taken from the study products during the Ad Libitum Session topography assessment
Measured: 60 minutes
Study product use
Change in weight of study products during the PK Session
Measured: 5 minutes
Study product use
Number of puffs taken from the study products during the PK Session
Measured: 5 minutes
Safety and tolerability
Incidence of product-use emergent adverse events
Measured: 24 hours
Safety and tolerability
Incidence of product malfunction or misuse
Measured: 24 hours

Timeline

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

11 Sep 202014 Jan 2021

First posted9 Nov 2020
Study start11 Sep 2020
Primary completion4 Jan 2021
Study completion14 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04620616
Sponsor's protocol ID: RELX-002
Status last verified: Jan 2021
First submitted: 4 Nov 2020
Last updated: 19 Jan 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 Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Multi-Center, Cross-Over Study of Adult Electronic Nicotine Delivery Systems (ENDS) Consumers to Assess Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With RELX Infinity ENDS
ClinicalTrials.gov ID: NCT04620616
Acronym / sponsor ID: RELX-002
Conditions: Electronic Cigarette Use
Keywords: Electronic Nicotine Delivery System, Nicotine, Pharmacokinetics, Abuse Liability, Topography, E-cigarette
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Cheerain HK LimitedIndustry (pharma, biotech, devices)
Study start: 11 Sep 2020 (actual)
Primary completion: 4 Jan 2021 (actual)
Study completion: 14 Jan 2021 (actual)
First posted: 9 Nov 2020 (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.

Study design

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

Arm	Type	Receives
Product Use Sequence 1	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - RELX ENDS menthol flavor Period 3 - Usual Brand ENDS
Product Use Sequence 2	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS tobacco flavor
Product Use Sequence 3	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS tobacco flavor Period 3 - RELX ENDS menthol flavor
Product Use Sequence 4	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS menthol flavor Period 3 - RELX ENDS tobacco flavor
Product Use Sequence 5	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS menthol flavor
Product Use Sequence 6	Experimental	Other: RELX ENDS Tobacco Flavor, Other: RELX ENDS Menthol Flavor, Other: Subject Usual Brand ENDSProducts use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - RELX ENDS tobacco flavor Period 3 - Usual Brand ENDS

Who may qualify

Ages: 22 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
Is 22 to 59 years of age, inclusive, at the time of consent.
Has been a daily ENDS consumer for at least 3 months prior to Screening and through Check-in. Brief periods of abstinence (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where vaping was prohibited) ≥ 30 days prior to Screening will be permitted at the discretion of an Investigator.
Reports weekly use of at least 3 mL of e-liquid from an ENDS product at Screening.
Has a urine cotinine concentration ≥ of 200 ng/mL at Screening and Check-in.

Key exclusion criteria (30 listed)

Has a history or presence of clinically significant uncontrolled gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that would jeopardize the safety of the subject or impact the validity of the study results.
Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results.
Has a positive test for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen, or Hepatitis C Antibody.
Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Check-in.
Has a fever (> 100.5°F) at Screening or Check-in.

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
RELX ENDS Tobacco FlavorAd libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions	Other	Product Use Sequence 1, Product Use Sequence 2, Product Use Sequence 3, Product Use Sequence 4, Product Use Sequence 5, Product Use Sequence 6
RELX ENDS Menthol FlavorAd libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions	Other	Product Use Sequence 1, Product Use Sequence 2, Product Use Sequence 3, Product Use Sequence 4, Product Use Sequence 5, Product Use Sequence 6
Subject Usual Brand ENDSAd libitum use of the usual brand product during 8-hour and 5-minute use sessions	Other	Product Use Sequence 1, Product Use Sequence 2, Product Use Sequence 3, Product Use Sequence 4, Product Use Sequence 5, Product Use Sequence 6

Primary outcome

Nicotine uptake
Time frame: 120 minutes
PK Session baseline-adjusted maximum plasma nicotine concentration [Cmax]
Nicotine uptake
Time frame: 120 minutes
PK Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-120)]

22 secondary outcomes

Nicotine uptake - PK Session
Time frame: 15 minutes
Nicotine uptake - PK Session
Time frame: 120 minutes
Nicotine uptake - Ad Libitum Session
Time frame: 480 minutes
Subject effects as measured by the Modified Product Evaluation Scale
Time frame: 480 minutes
Subject effects as measured by the Future Intent to Use questionnaire
Time frame: 480 minutes
Subject effects as measured by the Urge to Vape questionnaire
Time frame: 120 minutes
Subject effects as measured by the Product Liking questionnaire
Time frame: 120 minutes
Physiologic effects as measured by heart rate
Time frame: 480 minutes
Physiologic effects as measured by heart rate
Time frame: 120 minutes
Physiologic effects as measured by blood pressure
Time frame: 480 minutes
Physiologic effects as measured by blood pressure
Time frame: 120 minutes
Study product use
Time frame: 480 minutes
Study product use
Time frame: 480 minutes
Study product use
Time frame: 60 minutes
Study product use
Time frame: 60 minutes
Study product use
Time frame: 60 minutes
Study product use
Time frame: 60 minutes
Study product use
Time frame: 60 minutes
Study product use
Time frame: 5 minutes
Study product use
Time frame: 5 minutes
Safety and tolerability
Time frame: 24 hours
Safety and tolerability
Time frame: 24 hours

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 19 Jan 2021.
Individual participant dataSharing planned: No

Related trials for Electronic Cigarette Use

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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.

Donald Graff, PharmD study director

Sponsor Representative

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

Questions about this trial

What is this clinical trial studying?

A study testing RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor and Subject Usual Brand ENDS in people with Electronic Cigarette Use, run by Cheerain HK Limited at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nicotine uptake (time frame: 120 minutes). The study lists 2 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 NCT04620616.

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 19 Jan 2021.