ClinicalTrials.gg
Not yet recruitingNCT07677280Updated Jun 30, 2026

A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products

An interventional study of P2515910 and P2512610 in Cigarette Smokers, sponsored by RAI Services Company. Not yet recruiting at 2 sites in United Kingdom. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cigarette Smokers
03

In context

Lead sponsor

RAI Services Company is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

First submitted after RAI Services Company became part of British American Tobacco.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 methods to prevent pregnancy.

    a) 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. 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 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    HTP Device 1

    Other: P2515910 · Other: P2512610

  • Experimental
    HTP Device 2

    Other: P2515910 · Other: P2512610

Interventions

  • OtherP2515910

    Tobacco Flavor

  • OtherP2512610

    Menthol Flavor

06

What researchers measure

Primary outcomes

  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.

    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 \[SAP\]

    Time frame: 5 days

Secondary outcomes

  1. 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

    Time frame: 5 days

  2. 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

    Time frame: 5 days

  3. Determine the average daily consumption (ADC) of CC smoked, sticks consumed, and other TNPs used

    Through self-reported questionnaires

    Time frame: 5 days

  4. 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)

    Time frame: 5 days

  5. Characterize demographic characteristics

    Time frame: 5 days

  6. Determine the safety profile (i.e., adverse events/experiences [AEs]) of the Study IP

    Time frame: 5 days

07

Study locations

2 sites
  • Cheshunt Community Sports Park
    Cheshunt, United Kingdom
  • Channing Hall
    Sheffield, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07677280
Collaborators
IPSOS
Responsible party
Sponsor
First posted
Jun 30, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jun 30, 2026

Study contacts

Montgomery Hedgecock
Contact
montgomery_hedgecock@rjrt.com
336-741-3761
Melissa Tapia, Ph.D.
study director · RAIS Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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