A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products (NCT07677280) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products
United Kingdom200 participantsStarted 2026-06
Plain-language summary
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with two variants of HTP consumables ("sticks"), collectively referred to as the study investigational products (Study IP), among a sample of 240 primary users of combustible cigarettes in the United Kingdom (UK). Participants will be using the products for five days at home. Participants demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Participants will be asked to complete daily surveys using a survey link. Surveys will collect data on the number of CC smoked and number of sticks consumed the previous day in addition to any other tobacco or nicotine product used. In addition, at the end of the study, participants will complete a survey regarding overall product liking and purchase intent.
Who can participate
Age range
21 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:
* Ability to read, understand, and be willing to sign an ICF and complete questionnaires written in English.
* Generally healthy male or female, between age 21-65 years (inclusive at the time of consent), verified with government-issued identification.
* All female (assigned at birth) candidate participants and those who identify as "intersex" or "unknown" during screening who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
* Self-report currently smoking at least five CPD on smoking days in the past 30 days.
* Smoke CC on at least 27 days out of last 30 days.
* Have smoked at least 100 factory-made filtered CC in their lifetime prior to SEV.
* Indicate a willingness to use an HTP.
* Agree to participate in the study and to abide by the study restrictions and requirements, including the use of the assigned Study IP, as described in the ICF.
* Agree not to allow any other person to use any product provided to them for use during this study.
Exclusion Criteria:
* Female participants who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next 6 months from the study start date.
* Women who self-report they are not intending to use adequate contraception methods to prevent pregnancy.
a) Examples of acceptable contraception methods are, but not limited to: i. Surgical sterilization (hysterectomy, …
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
1
To measure the puffing topography of primary CC smokers when using either the glo or glo plus device with one of two stick variants during a five-day use period.