Electronic Cigarette UseNCT04708106
Characterization of Product Use in Smokers Switching From Cigarettes to a RELX Electronic Nicotine Delivery System
A study testing RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor and RELX ENDS Tobacco and Menthol Flavors in people with Electronic Cigarette Use, run by Cheerain HK Limited at 5 sites in United States.
Trial summary
The study will assess product use behaviors, biomarkers of exposure, subjective effects, and safety in smokers who switch to a RELX ENDS over 8-weeks. 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, RELX ENDS Menthol Flavor and RELX ENDS Tobacco and Menthol Flavors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Oct 2020to 7 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 65 years of age, inclusive, at the time of consent.
- Is willing to comply with the requirements of the study.
- Reports typically smoking 5 or more combustible CPD at Screening.
- Has been a daily smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) ≥ 56 days prior to Screening will be permitted at the discretion of the Investigator.
- Has a positive urine cotinine test (≥ 200 ng/mL) at Screening and Test Visit 1.
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- Has an exhaled carbon monoxide (ECO) value > 10 ppm at Screening and Test Visit 1.
- Has daily access to a cell phone for daily product use reporting.
- If female, meets 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) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels.
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, in the opinion of the Investigator, 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, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the Investigator.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
- Has a positive COVID-19 test at Screening or during the study.
- Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1.
- Has a fever (> 100.5°F) at Screening or Test Visit 1.
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- Has a body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at Screening.
- Has a systolic blood pressure < 90 mmHg or > 150 mmHg, diastolic blood pressure < 40 mmHg or > 95 mmHg, or heart rate < 40 bpm or > 99 bpm at Screening.
- Has a post-bronchodilator forced expiratory volume in 1 second:forced vital capacity (FEV1:FVC) ratio < 0.7 and FEV1 < 50% of predicted at Screening.
- Has a post-bronchodilator FEV1 increase ≥ 12% and > 200 mL from pre- to post-bronchodilator at Screening.
- Has used an ENDS product on >7 days during each of the 3 months prior to Screening or any use from Screening to Test Visit 1 other than as may be required for this study.
- Reports use of a very-low nicotine content cigarette (e.g., Moonlight, Spectrum, VLN) as usual brand.
- Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS products (e-cigarettes), roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Test Visit 1.
- Has used any products for the purpose of smoking cessation, including, but not limited to, nicotine replacement therapies, varenicline (Chantix), or buproprion (Zyban) from 30 days prior to Screening through the duration of the study.
- Is a self-reported puffer (i.e., draws smoke from the cigarette into the mouth and throat but does not inhale).
- Is postponing a planned smoking quit attempt in order to participate in the study.
- Has a history of drug or alcohol abuse within 12 months prior to Screening, as determined by the Investigator.
- Is allergic to PG or glycerin.
- Has a positive urine drug or alcohol breath test at Screening or Test Visit 1. At the discretion of the investigator, a subject testing positive for tetrahydrocannabinol may be permitted to participate if the subject reports use by routes other than inhalation.
- If female, the subject is pregnant, breastfeeding, or intends to become pregnant from Screening through the duration of the study.
- Has been treated for depression, diabetes, asthma, emphysema, or chronic obstructive pulmonary disease within 12 months prior to Test Visit 1.
- Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 12 months prior to Screening 1.
- Has a planned surgery that would occur during study participation.
- Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Test Visit 1.
- Is or has a first-degree relative (e.g., spouse, parent, sibling, or 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, or child) who is a current employee of the clinic site.
- Is or has a first-degree relative (e.g., spouse, parent, sibling, or child) who is a current employee of the Sponsor.
- Has previously taken part in (from completion of any baseline measurements), has been withdrawn from, or has completed this study.
- In the opinion of the Investigator, the subject should not participate in this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pillar Clinical Research
Bentonville, Arkansas, 72712
AMR - Knoxville
Knoxville, Tennessee, 37920
AMR - Las Vegas
Las Vegas, Nevada, 89119
AMR - Lexington
Lexington, Kentucky, 40509
QPS
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Multi-Center, Open-Label, Parallel-Cohort Study to Characterize Product Use in Smokers Switching From Combustible Cigarettes to a RELX Electronic Nicotine Delivery System (ENDS)
The study will assess product use behaviors, biomarkers of exposure, subjective effects, and safety in smokers who switch to a RELX ENDS over 8-weeks.
- Conditions
- Electronic Cigarette Use
- Being tested
- RELX ENDS Tobacco Flavor, RELX ENDS Menthol Flavor, RELX ENDS Tobacco and Menthol Flavors
- Keywords
- Electronic Nicotine Delivery System, Biomarkers, Subjective Effects, 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
RELX ENDS Menthol FlavorOther
Ad libitum use of the RELX ENDS Menthol product
RELX ENDS Tobacco and Menthol FlavorsOther
Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products
| Study group | Role | What they receive |
|---|---|---|
| RELX ENDS Tobacco Flavor | Experimental | Switch from combustible cigarettes to RELX ENDS Tobacco Flavor for 56 days Receives: Other: RELX ENDS Tobacco Flavor |
| RELX ENDS Menthol Flavor | Experimental | Switch from combustible cigarettes to RELX ENDS Menthol Flavor for 56 days Receives: Other: RELX ENDS Menthol Flavor |
| RELX ENDS Tobacco and Menthol Flavors | Experimental | Switch from combustible cigarettes to RELX ENDS Tobacco and Menthol Flavor for 56 days Receives: Other: RELX ENDS Tobacco and Menthol Flavors |
| Continue-smoking | No intervention | Continue smoking combustible cigarettes for 56 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly RELX ENDS product use
Self-reported number of RELX ENDS pods started each week.
Measured: 56 days
Daily number of cigarettes smoked
Self-reported number of cigarettes smoked daily by study week.
Measured: 56 days
Number of puffs from the RELX ENDS each day
Self-reported number of puffs from the RELX ENDS daily by study week (0, < 100, ≥ 100 per day).
Measured: 56 days
Secondary outcomes (17)
Biomarkers of exposure measured in blood
Change in carbon monoxide concentration in the blood.
Measured: Baseline, Day 28, and Day 56
Biomarkers of tobacco exposure measured in urine
Change in creatinine-adjusted NNAL, NNN, 3-HPMA, CEMA, HMPMA, S-PMA, HEMA, 1-OHP, o-toluidine, nicotine equivalents, and propylene glycol excreted in urine.
Measured: Baseline, Day 28, and Day 56
Subjective effects as measured by the Penn State [Electronic] Cigarette Dependence Index (PS[E]CDI)
Change in product dependence as measured by the PSCDI/PSECDI total score. Total scores may range for 0 to 20, with higher levels of dependence associated with higher scores.
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Cough Questionnaire
Change in self-reported cough symptoms as measured by responses to the Cough Questionnaire.
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Change in smoking urge as measured by the QSU-Brief factor 1 and factor 2 scores. Questionnaire responses are measured on a Likert scale range of 1 [not at all] to 7 [extremely].
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Change in withdrawal symptoms as measured by the MTWS-R total score, which includes the DSM-5 and craving items from the Minnesota Tobacco Withdrawal Scale. Questionnaire responses are measured on a Likert scale range of 0 [none] to 4 [severe]).
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Modified Product Evaluation Scale (mPES)
Change in product assessments as measured by mPES satisfaction, psychological reward, aversion, and relief subscale scores. Questionnaire responses are measured on a Likert scale range of 1 [not at all] to 7 [extremely].
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Future Intent to Use Questionnaire
Change in future intent to use cigarettes and ENDS products as measured by responses to the Future Intent to Use Questionnaire. Questionnaire responses are measured on a Likert scale range of 1 [extremely unlikely] to 7 [extremely likely].
Measured: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective Effects as measured by the Health Effects Perceptions Questionnaire
Harmful and addictiveness perceptions as measured by responses to the Health Effects Perceptions Questionnaire.
Measured: Baseline and Day 56
Puff topography - number of puffs
Change in the number of puffs during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
Puff topography - puff duration
Change in puff duration during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
Puff topography - puff volume
Change in puff volume during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
Puff topography - peak puff flow rate
Change in peak puff flow rate during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
Puff topography - average flow rate
Change in average flow rate during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
Puff topography - inter-puff interval
Change in inter-puff interval during a 1-hour puff topography session.
Measured: Baseline, Day 28, and Day 56
RELX ENDS product use
Change in pod weight during a 1-hour topography session
Measured: Day 28 and Day 56
Incidence of product-use emergent adverse events [Safety and Tolerability]
Incidence of product-use emergent adverse events
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start15 Oct 2020
- Primary completion1 Jul 2021
- Study completion7 Jul 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 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, Sponsor RepresentativeMark Adams, MD, Principal investigator, AMR - Lexington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708106
- Sponsor's protocol ID
- RELX-003
- Status last verified
- Jul 2021
- First submitted
- 8 Jan 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Open-Label, Parallel-Cohort Study to Characterize Product Use in Smokers Switching From Combustible Cigarettes to a RELX Electronic Nicotine Delivery System (ENDS)
- ClinicalTrials.gov ID
- NCT04708106
- Acronym / sponsor ID
- RELX-003
- Conditions
- Electronic Cigarette Use
- Keywords
- Electronic Nicotine Delivery System, Biomarkers, Subjective Effects, Topography, E-cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Cheerain HK LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 13 Jan 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.
The study will assess product use behaviors, biomarkers of exposure, subjective effects, and safety in smokers who switch to a RELX ENDS over 8-weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RELX ENDS Tobacco Flavor | Experimental | Other: RELX ENDS Tobacco FlavorSwitch from combustible cigarettes to RELX ENDS Tobacco Flavor for 56 days |
| RELX ENDS Menthol Flavor | Experimental | Other: RELX ENDS Menthol FlavorSwitch from combustible cigarettes to RELX ENDS Menthol Flavor for 56 days |
| RELX ENDS Tobacco and Menthol Flavors | Experimental | Other: RELX ENDS Tobacco and Menthol FlavorsSwitch from combustible cigarettes to RELX ENDS Tobacco and Menthol Flavor for 56 days |
| Continue-smoking | No intervention | –Continue smoking combustible cigarettes for 56 days |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
- Is 22 to 65 years of age, inclusive, at the time of consent.
- Is willing to comply with the requirements of the study.
- Reports typically smoking 5 or more combustible CPD at Screening.
- Has been a daily smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) ≥ 56 days prior to Screening will be permitted at the discretion of the Investigator.
Key exclusion criteria (29 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, in the opinion of the Investigator, 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, electrocardiogram (ECG), or clinical laboratory results, in the opinion of the Investigator.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
- Has a positive COVID-19 test at Screening or during the study.
- Has had an acute illness (e.g., upper respiratory infection, viral infection) within 14 days prior to Test Visit 1.
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 | Other | RELX ENDS Tobacco Flavor |
| RELX ENDS Menthol FlavorAd libitum use of the RELX ENDS Menthol product | Other | RELX ENDS Menthol Flavor |
| RELX ENDS Tobacco and Menthol FlavorsAd libitum use of the RELX ENDS Tobacco and Menthol Flavor products | Other | RELX ENDS Tobacco and Menthol Flavors |
Primary outcome
Weekly RELX ENDS product use
Time frame: 56 days
Self-reported number of RELX ENDS pods started each week.
Daily number of cigarettes smoked
Time frame: 56 days
Self-reported number of cigarettes smoked daily by study week.
Number of puffs from the RELX ENDS each day
Time frame: 56 days
Self-reported number of puffs from the RELX ENDS daily by study week (0, < 100, ≥ 100 per day).
17 secondary outcomes
Biomarkers of exposure measured in blood
Time frame: Baseline, Day 28, and Day 56
Biomarkers of tobacco exposure measured in urine
Time frame: Baseline, Day 28, and Day 56
Subjective effects as measured by the Penn State [Electronic] Cigarette Dependence Index (PS[E]CDI)
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Cough Questionnaire
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Modified Product Evaluation Scale (mPES)
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective effects as measured by the Future Intent to Use Questionnaire
Time frame: Baseline, Day 14, Day 28, Day 42, and Day 56
Subjective Effects as measured by the Health Effects Perceptions Questionnaire
Time frame: Baseline and Day 56
Puff topography - number of puffs
Time frame: Baseline, Day 28, and Day 56
Puff topography - puff duration
Time frame: Baseline, Day 28, and Day 56
Puff topography - puff volume
Time frame: Baseline, Day 28, and Day 56
Puff topography - peak puff flow rate
Time frame: Baseline, Day 28, and Day 56
Puff topography - average flow rate
Time frame: Baseline, Day 28, and Day 56
Puff topography - inter-puff interval
Time frame: Baseline, Day 28, and Day 56
RELX ENDS product use
Time frame: Day 28 and Day 56
Incidence of product-use emergent adverse events [Safety and Tolerability]
Time frame: 56 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 22 Jul 2021.
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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
Mark Adams, MD principal investigator
AMR - Lexington
5 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 RELX ENDS Tobacco and Menthol Flavors in people with Electronic Cigarette Use, run by Cheerain HK Limited at 5 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 14 inclusion and 29 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Weekly RELX ENDS product use (time frame: 56 days). The study lists 3 primary outcomes in all. 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 22 Jul 2021.