Cigarette SmokersNCT07677280
A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products
A study testing P2515910 and P2512610 in people with Cigarette Smokers, run by RAI Services Company at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smokers
- What is being tested?
- P2515910 and P2512610
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
- Examples of acceptable contraception methods are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); ii. Established use of oral, implantable, injectable, or transdermal methods of contraception associated with inhibition of ovulation; iii. Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; iv. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); v. Vasectomized partner; vi. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and vii. Post-menopausal who are not on hormone replacement therapy.
- Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Individuals who self-report having pacemakers or other embedded electronic medical devices.
- Individuals who self-report having an unstable heart condition, severe hypertension or diabetes.
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- Individuals who self-report they are sensitive to nicotine.
- Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
- Individuals who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
- Individuals who are employed by a company that manufactures tobacco, HTPs, marketing or in ongoing litigation with a tobacco company.
- Individuals who self-report that they are planning to quit all nicotine products in the next three months.
- Individuals who are personally, have household members, or have close family or friends in ongoing or past litigation with a company that manufactures tobacco or HTPs.
- People who have taken part in a tobacco/nicotine research study in the past 30 days.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
Cheshunt Community Sports Park
Cheshunt
Channing Hall
Sheffield
About this study
Official title: A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products (Glo and Glo Plus)
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.
- Conditions
- Cigarette Smokers
- Being tested
- P2515910, P2512610
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2515910Other
Tobacco Flavor
P2512610Other
Menthol Flavor
| Study group | Role | What they receive |
|---|---|---|
| HTP Device 1 | Experimental | Not described Receives: Other: P2515910; Other: P2512610 |
| HTP Device 2 | Experimental | Not described Receives: Other: P2515910; Other: P2512610 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The primary endpoints of this study will be measured in using built-in topography measures and the product use behavior (PUB) instrument (Study Arm 1 only). The data will include:
- Mean number of puffs per day
- Mean estimated puff volume (Study Arm 1) only)
- Mean puff duration
- Mean duration between puffs taken (inter-puff-interval; IPI)
- Number of stick consumption episodes per day (as defined in the statistical analysis plan [SAP]
Measured: 5 days
Secondary outcomes (6)
Determine the frequency of use of the glo and glo plus devices in Standard and Boost Mode
This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device
Measured: 5 days
Determine the frequency of use of the glo plus pen detached from the charger pack (Study Arm 2 only)
This secondary endpoint will be measured using the built-in topography measures through the Product Use Behavior (PUB) device
Measured: 5 days
Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used
Through self-reported questionnaires
Measured: 5 days
Determine overall product liking and purchase intent
Overall Product Liking: 1 (Strongly Dislike) - 10 (Strongly Like) Purchase Intent: 1 (Definitely would not purchase) - 10 (Definitely would purchase)
Measured: 5 days
Characterize demographic characteristics
Measured: 5 days
Determine the safety profile (i.e., adverse events/experiences [AEs]) of the Study IP
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokersStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IPSOS
- Responsible party
- Sponsor
- Investigators
- Melissa Tapia, Ph.D., Study director, RAIS Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677280
- Sponsor's protocol ID
- PHI252503
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products (Glo and Glo Plus)
- ClinicalTrials.gov ID
- NCT07677280
- Acronym / sponsor ID
- PHI252503
- Conditions
- Cigarette Smokers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- IPSOS
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Jun 2026 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HTP Device 1 | Experimental | Other: P2515910, Other: P2512610 |
| HTP Device 2 | Experimental | Other: P2515910, Other: P2512610 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
- Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Individuals who self-report having pacemakers or other embedded electronic medical devices.
- Individuals who self-report having an unstable heart condition, severe hypertension or diabetes.
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 |
|---|---|---|
| P2515910Tobacco Flavor | Other | HTP Device 1, HTP Device 2 |
| P2512610Menthol Flavor | Other | HTP Device 1, HTP Device 2 |
Primary outcome
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.
Time frame: 5 days
The primary endpoints of this study will be measured in using built-in topography measures and the product use behavior (PUB) instrument (Study Arm 1 only). The data will include: * Mean number of puffs per day * Mean estimated puff volume (Study Arm 1) only) * Mean puff duration * Mean duration between puffs taken (inter-puff-interval; IPI) * Number of stick consumption episodes per day (as defined in the statistical analysis plan [SAP]
6 secondary outcomes
Determine the frequency of use of the glo and glo plus devices in Standard and Boost Mode
Time frame: 5 days
Determine the frequency of use of the glo plus pen detached from the charger pack (Study Arm 2 only)
Time frame: 5 days
Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used
Time frame: 5 days
Determine overall product liking and purchase intent
Time frame: 5 days
Characterize demographic characteristics
Time frame: 5 days
Determine the safety profile (i.e., adverse events/experiences [AEs]) of the Study IP
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- 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.
Melissa Tapia, Ph.D. study director
RAIS Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P2515910 and P2512610 in people with Cigarette Smokers, run by RAI Services Company at 2 sites in United Kingdom.
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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 30 Jun 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Montgomery Hedgecock (336-741-3761, montgomery_hedgecock@rjrt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 5 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 30 Jun 2026.