Electronic Cigarette UseNCT05134415
Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers
A study testing RELX ENDS Tobacco Flavor 1, RELX ENDS Tobacco Flavor 2 and RELX ENDS Menthol Flavor 1 in people with Electronic Cigarette Use, run by Cheerain HK Limited at 1 site in United States.
Trial summary
This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS). Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use
- What is being tested?
- RELX ENDS Tobacco Flavor 1, RELX ENDS Tobacco Flavor 2 and RELX ENDS Menthol Flavor 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 1 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is 22 to 65 years of age, inclusive, at the time of consent.
- Has used a closed-system ENDS product on most days during the 60 days prior to Screening (no use on up to 8 days total is allowed). Dual use with open-system products will be allowed provided that the closed-system is the predominant system used (based on self-reported volume of e-liquid used).
- Reports a tobacco or menthol/mint flavored e-liquid as the most commonly used flavor (based on self-reported volume of e-liquid used) during the 30 days prior to screening.
- Agrees to maintain product use described in Criteria 3 and 4 from Screening through Test Visit 1.
- Has a urine cotinine concentration ≥ 200 ng/mL at Screening.
- Has an ECO concentration < 10 ppm at Screening and Test Visit 1.
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- 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 and during the study. 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.
- 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).
- Is willing to comply with the requirements of the study.
- Provides voluntary consent to participate in the study as documented on the signed ICF.
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 at Screening, including, but not limited to, the following:
- Has a history of drug or alcohol abuse within 12 months of Screening.
- Has a systolic BP <90 mmHg or >160 mmHg, diastolic BP <40 mmHg or >95 mmHg, or HR <40 bpm or >99 bpm at Screening.
- 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 been treated chronically for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months of Test Visit 1.
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- Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1 that would jeopardize the safety of the subject or impact the validity of the study results.
- 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 and/or
- Body temperature ≥100.4°F and/or
- Laboratory test results suggestive of active or recent exposure to SARS CoV 2.
- Has a BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
- Is allergic to or intolerant of components of the product e-liquid, including but not limited to, menthol, propylene glycol, or glycerin.
- Has a positive urine drug or alcohol test at Screening..
- If female, has a positive pregnancy test, is breastfeeding or lactating, or intends to become pregnant from Screening through Test Visit 3.
- Is a current combustible cigarette, cigar, or little cigar smoker at Screening (more than 5 product uses in the previous 30 days).
- Has used other tobacco- or nicotine-containing products other than ENDS products (e.g., combustible cigarettes, cigars, or little cigars, snuff, pouches, chewing tobacco, nicotine inhalers, nicotine patches, nicotine sprays, nicotine lozenges, or nicotine gum) from 14 days prior to Test Visit 1.
- 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 Test Visit 3.
- Draws aerosol from the usual brand ENDS into the mouth and throat but does not inhale as observed by the clinic staff during Screening.
- Is postponing a planned vaping quit attempt in order to participate in the study.
- Has donated plasma within 7 days prior to Test Visit 1.
- Has provided a whole blood donation, had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Test Visit 1.
- 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 Test Visit 1.
- 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 (including the Sponsor) 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).
- 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
1 site in 1 country.
United States1 site
Los Angeles Clinical Trials
Burbank, California, 91505
About this study
Official title: A Randomized, Single-Blind, Two-Arm, Cross-Over Study to Compare Use of Two Tobacco and Two Menthol Flavor e-Liquids in Electronic Nicotine Delivery System Users
This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).
- Conditions
- Electronic Cigarette Use
- Being tested
- RELX ENDS Tobacco Flavor 1, RELX ENDS Tobacco Flavor 2, RELX ENDS Menthol Flavor 1, RELX ENDS Menthol Flavor 2
- Keywords
- Electronic Nicotine Delivery System, Nicotine, Topography, Pharmacokinetics, E-cigarette, Subjective effects
- 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 Flavor 1Other
2-week ad libitum use of the RELX ENDS tobacco flavor 1
RELX ENDS Tobacco Flavor 2Other
2-week ad libitum use of the RELX ENDS tobacco flavor 2
RELX ENDS Menthol Flavor 1Other
2-week ad libitum use of the RELX ENDS menthol flavor 1
RELX ENDS Menthol Flavor 2Other
2-week ad libitum use of the RELX ENDS menthol flavor 2
| Study group | Role | What they receive |
|---|---|---|
| Product Use Sequence 1 | Experimental | Period 1 - RELX ENDS tobacco flavor 1 Period 2 - RELX ENDS tobacco flavor 2 Receives: Other: RELX ENDS Tobacco Flavor 1; Other: RELX ENDS Tobacco Flavor 2 |
| Product Use Sequence 2 | Experimental | Period 1 - RELX ENDS tobacco flavor 2 Period 2 - RELX ENDS tobacco flavor 1 Receives: Other: RELX ENDS Tobacco Flavor 1; Other: RELX ENDS Tobacco Flavor 2 |
| Product Use Sequence 3 | Experimental | Period 1 - RELX ENDS menthol flavor 1 Period 2 - RELX ENDS menthol flavor 2 Receives: Other: RELX ENDS Menthol Flavor 1; Other: RELX ENDS Menthol Flavor 2 |
| Product Use Sequence 4 | Experimental | Period 1 - RELX ENDS menthol flavor 2 Period 2 - RELX ENDS menthol flavor 1 Receives: Other: RELX ENDS Menthol Flavor 1; Other: RELX ENDS Menthol Flavor 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study product use - daily pod use
The number of pods used per day during the 14-day ambulatory period
Measured: 14 days
Secondary outcomes (22)
Study product use - e-liquid consumption per pod
The amount of e-liquid consumed per pod during the 14-day ambulatory period
Measured: 14 days
Study product use - e-liquid consumption per day
The amount of e-liquid consumed each day during the 14-day ambulatory period
Measured: 14 days
Puff topography - number of puffs
Number of puffs taken from the study products during the PK Session
Measured: 5 minutes
Puff topography - duration of puffs
Duration of puffs taken from the study products during the PK Session
Measured: 5 minutes
Puff topography - volume of puffs
Volume of puffs taken from the study products during the PK Session
Measured: 5 minutes
Puff topography - peak flow rate of puffs
Peak flow rate of puffs taken from the study products during the PK Session
Measured: 5 minutes
Puff topography - average flow rate of puffs
Average flow rate of puffs taken from the study products during the PK Session
Measured: 5 minutes
Puff topography - inter-puff interval
Inter-puff interval of puffs taken from the study products during the PK Session
Measured: 5 minutes
Study product use - e-liquid consumption (PK session)
Change in pod weight of pods used during the PK Session
Measured: 5 minutes
Subjective effects - dependence
Nicotine dependence as measured by the Penn State Electronic Cigarette Dependence Index (PSECDI) total score. Total scores may range from 0 to 20, with higher levels of dependence associated with higher scores.
Measured: 14 days
Subjective effects - craving
Craving as measured by the Questionnaire of Vaping Craving (QVC) average score. Questionnaire responses are measured on a Likert scale range of 1 [strongly disagree] to 7 [strongly agree].
Measured: 14 days
Subjective effects - withdrawal symptoms
Withdrawal symptoms as measured by the Minnesota Tobacco Withdrawal Scale - Revised (MTWS-R), which includes the DSM-5 and craving items from the MTWS. Questionnaire responses are measured on a Likert scale range of 0 [none] to 4 [severe]).
Measured: 14 days
Subjective effects - product effects
Product effects as measured by the Modified Product Evaluation Scale (mPES) satisfaction, psychological reward, aversion, and relief subscale and individual item scores. Questionnaire responses are measured on a Likert scale range of 1 [not at all] to 7 [extremely].
Measured: 14 days
Subjective effects - future intent to use product
Future intent to use the product as measured by the Future Intent to Use Questionnaire (FIU). Questionnaire responses are measured on a Likert scale range of 1 [extremely unlikely] to 7 [extremely likely].
Measured: 14 days
Subjective effects - maximum acute urge to vape reduction
Maximum urge to vape reduction (Emax_R) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Measured: 30 minutes
Subjective effects - overall acute urge to vape reduction
Overall urge to vape reduction (AOEC0-30) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Measured: 30 minutes
Subjective effects - time to maximum acute urge to vape reduction
Time to the maximum urge to vape reduction (TEmax_R) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Measured: 30 minutes
Nicotine uptake - maximum nicotine concentration
Baseline-adjusted maximum plasma nicotine concentration [Cmax]
Measured: 30 minutes
Nicotine uptake - overall nicotine uptake
Baseline-adjusted area under the nicotine concentration-time curve [AUC(0-30)]
Measured: 30 minutes
Nicotine uptake - time to maximum nicotine concentration
Time of the maximum post-baseline nicotine concentration [Tmax]
Measured: 30 minutes
Safety and tolerability - adverse events
Incidence of product-use emergent adverse events
Measured: 14 days
Safety and tolerability - product malfunction or misuse
Incidence of product malfunction or misuse
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start12 Oct 2021
- Primary completion12 Nov 2021
- Study completion1 Dec 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheerain HK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Graff, PharmD, Study director, RELX International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134415
- Sponsor's protocol ID
- RELX-004
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Two-Arm, Cross-Over Study to Compare Use of Two Tobacco and Two Menthol Flavor e-Liquids in Electronic Nicotine Delivery System Users
- ClinicalTrials.gov ID
- NCT05134415
- Acronym / sponsor ID
- RELX-004
- Conditions
- Electronic Cigarette Use
- Keywords
- Electronic Nicotine Delivery System, Nicotine, Topography, Pharmacokinetics, E-cigarette, Subjective effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cheerain HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Nov 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.
This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Product Use Sequence 1 | Experimental | Other: RELX ENDS Tobacco Flavor 1, Other: RELX ENDS Tobacco Flavor 2Period 1 - RELX ENDS tobacco flavor 1 Period 2 - RELX ENDS tobacco flavor 2 |
| Product Use Sequence 2 | Experimental | Other: RELX ENDS Tobacco Flavor 1, Other: RELX ENDS Tobacco Flavor 2Period 1 - RELX ENDS tobacco flavor 2 Period 2 - RELX ENDS tobacco flavor 1 |
| Product Use Sequence 3 | Experimental | Other: RELX ENDS Menthol Flavor 1, Other: RELX ENDS Menthol Flavor 2Period 1 - RELX ENDS menthol flavor 1 Period 2 - RELX ENDS menthol flavor 2 |
| Product Use Sequence 4 | Experimental | Other: RELX ENDS Menthol Flavor 1, Other: RELX ENDS Menthol Flavor 2Period 1 - RELX ENDS menthol flavor 2 Period 2 - RELX ENDS menthol flavor 1 |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is 22 to 65 years of age, inclusive, at the time of consent.
- Has used a closed-system ENDS product on most days during the 60 days prior to Screening (no use on up to 8 days total is allowed). Dual use with open-system products will be allowed provided that the closed-system is the predominant system used (based on self-reported volume of e-liquid used).
- Reports a tobacco or menthol/mint flavored e-liquid as the most commonly used flavor (based on self-reported volume of e-liquid used) during the 30 days prior to screening.
- Agrees to maintain product use described in Criteria 3 and 4 from Screening through Test Visit 1.
- Has a urine cotinine concentration ≥ 200 ng/mL at Screening.
Key exclusion criteria (27 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 at Screening, including, but not limited to, the following:
- Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1 that would jeopardize the safety of the subject or impact the validity of the study results.
- Subjects who, in the judgment of the study physician, have recent or active COVID 19 infection, as evidenced by the following:
- Has a BMI greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
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 Flavor 12-week ad libitum use of the RELX ENDS tobacco flavor 1 | Other | Product Use Sequence 1, Product Use Sequence 2 |
| RELX ENDS Tobacco Flavor 22-week ad libitum use of the RELX ENDS tobacco flavor 2 | Other | Product Use Sequence 1, Product Use Sequence 2 |
| RELX ENDS Menthol Flavor 12-week ad libitum use of the RELX ENDS menthol flavor 1 | Other | Product Use Sequence 3, Product Use Sequence 4 |
| RELX ENDS Menthol Flavor 22-week ad libitum use of the RELX ENDS menthol flavor 2 | Other | Product Use Sequence 3, Product Use Sequence 4 |
Primary outcome
Study product use - daily pod use
Time frame: 14 days
The number of pods used per day during the 14-day ambulatory period
22 secondary outcomes
Study product use - e-liquid consumption per pod
Time frame: 14 days
Study product use - e-liquid consumption per day
Time frame: 14 days
Puff topography - number of puffs
Time frame: 5 minutes
Puff topography - duration of puffs
Time frame: 5 minutes
Puff topography - volume of puffs
Time frame: 5 minutes
Puff topography - peak flow rate of puffs
Time frame: 5 minutes
Puff topography - average flow rate of puffs
Time frame: 5 minutes
Puff topography - inter-puff interval
Time frame: 5 minutes
Study product use - e-liquid consumption (PK session)
Time frame: 5 minutes
Subjective effects - dependence
Time frame: 14 days
Subjective effects - craving
Time frame: 14 days
Subjective effects - withdrawal symptoms
Time frame: 14 days
Subjective effects - product effects
Time frame: 14 days
Subjective effects - future intent to use product
Time frame: 14 days
Subjective effects - maximum acute urge to vape reduction
Time frame: 30 minutes
Subjective effects - overall acute urge to vape reduction
Time frame: 30 minutes
Subjective effects - time to maximum acute urge to vape reduction
Time frame: 30 minutes
Nicotine uptake - maximum nicotine concentration
Time frame: 30 minutes
Nicotine uptake - overall nicotine uptake
Time frame: 30 minutes
Nicotine uptake - time to maximum nicotine concentration
Time frame: 30 minutes
Safety and tolerability - adverse events
Time frame: 14 days
Safety and tolerability - product malfunction or misuse
Time frame: 14 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 13 Dec 2021.
- 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.
Donald Graff, PharmD study director
RELX International
1 site 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 1, RELX ENDS Tobacco Flavor 2 and RELX ENDS Menthol Flavor 1 in people with Electronic Cigarette Use, run by Cheerain HK Limited 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 14 inclusion and 27 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 13 Dec 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?
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?
Study product use - daily pod use (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2021.