CompletedNot Applicable

Characterization of Product Use in Smokers Switching From Cigarettes to a RELX Electronic Nicotine Delivery System

United States194 participantsStarted 2020-10-15

Plain-language 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.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weekly RELX ENDS product use

Timeframe: 56 days

Daily number of cigarettes smoked

Timeframe: 56 days

Number of puffs from the RELX ENDS each day

Timeframe: 56 days

Trial details

NCT IDNCT04708106

SponsorCheerain HK Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-01

View on ClinicalTrials.gov More Electronic Cigarette Use trials

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. 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.

Exclusion criteria

. 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.