Smoking CigaretteNCT07175987
A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products
A study testing RDTH002581, RDTH002580 and RDTH002582 in people with Smoking Cigarette, run by RAI Services Company at 1 site in United Kingdom.
Trial summary
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with three variants of HTP consumables ("sticks,"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cigarette
- What is being tested?
- RDTH002581, RDTH002580 and RDTH002582
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 25 Sep 2025
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 21-65 years (inclusive)
- Be self-reported current 'daily users' of at least 5 CPD and have smoked at least 100 cigarettes in their lifetime. ('daily users' defined as have smoked 5 CPD for at least 27 days out of last 30 days)
- 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
- Women who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next three months from the study start date.
- Women who self-report they are not using adequate methods to prevent pregnancy, which they intend to continue throughout the study.
- Examples of acceptable means of birth control are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal litigation/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 and not on hormone replacement Therapy
- People who self- report having pacemakers or other embedded electronic medical devices.
- People who self-report having heart disease, high blood pressure, diabetes, depression, or asthma.
- People who have ever used HTP.
Show all 18Show fewer
- People who self-report currently quitting or planning to quit all nicotine products in the next 3 months.
- People who self-report having participated in tobacco product research in the past 3 months.
- People who self-report themselves, or someone in their direct family or close friends, as working in one of the following areas:
- Advertising
- Journalism
- Media
- Insurance
- Marketing
- Market Research
- Manufacturer or retailer of tobacco or vapor products
- Public Relations
- Sale of Alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products in the UK
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with three variants of HTP consumables ("sticks,"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1).
In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
Read the detailed description
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices (glo and glo plus), with three variants of HTP consumables ("sticks," under the brand name "virto"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1).
In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
To account for respondent drop-out, the fieldwork team will recruit approximately 15% more participants for the CLT and approximately 20% more participants to the HUT phase.
- Conditions
- Smoking Cigarette
- Being tested
- RDTH002581, RDTH002580, RDTH002582, RDTH002578, RDTH002577
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDTH002581Other
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002580Other
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002582Other
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002578Other
Participants assigned to this Study Intervention will use the product only in the CLT portion of the study.
RDTH002577Other
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
RDTH002579Other
Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study.
| Study group | Role | What they receive |
|---|---|---|
| HTP Device (1) | Experimental | Participants will be randomized to one of three stick variants. Receives: Other: RDTH002581; Other: RDTH002580; Other: RDTH002582 |
| HTP Device (2) | Experimental | Participants will be randomized to one of three stick variants. Receives: Other: RDTH002578; Other: RDTH002577; Other: RDTH002579 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the puffing topography of primary combustible cigarette smokers when using either of the investigational HTP devices with one of three stick variants during CLT.
The primary endpoints will be measured in CLT using a desktop PA1. The data will be summarized using the overall mean per study arm (Study IP device) as well as mean per stick variant within arms.
Measured: 90 minutes
Secondary outcomes (4)
To determine the average daily consumption of sticks during HUT.
Participants will be asked to log the number of sticks used during the 5-day home use testing period.
Measured: 5 days
To assess purchase intent for participants using each of the study products before and after using the products.
Participants will be asked before and after using the product how likely they are to purchase the product on a scale from 1 to 10.
Measured: Through study completion
To describe subjective characteristics associated with product use, including overall liking
Participants will be asked their overall liking of the product on a 1-10 scale.
Measured: At study completion
To assess risk perceptions before using the products only.
Utilization of Tobacco Product Perception and Intentions (TPPI) survey data to understand the likelihood of certain tobacco and nicotine related use behaviors.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Sep 2025
- Primary completion12 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CigaretteStudies 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
- 212 participants (actual)
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, RAI Services Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175987
- Sponsor's protocol ID
- PHCB2IT20257
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2025
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products in the UK
- ClinicalTrials.gov ID
- NCT07175987
- Acronym / sponsor ID
- PHCB2IT20257
- Conditions
- Smoking Cigarette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Collaborators
- IPSOS
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 16 Sep 2025 (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 three variants of HTP consumables ("sticks,"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1).
In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
Detailed description
This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices (glo and glo plus), with three variants of HTP consumables ("sticks," under the brand name "virto"), collectively referred to as the study investigational products (Study IP), among a sample of n=198 primary users of combustible cigarettes at a central location testing (CLT) facility in the United Kingdom (UK). Puffing topography at the CLT will be measured using a desktop puffing analyzer device (PA1).
In addition to puffing topography measurements at the CLT, a tobacco product perceptions and intentions survey will be used to assess study participants' intent to purchase the Study IP, their risk perceptions, and their intended use behaviors. Participants' demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires.
Following completion of the CLT, a subset (n=100) of the originally enrolled population will participate in a 5-day home use testing (HUT) period in which they will use the Study IP for 5 days in their everyday environments to assess average daily consumption (ADC) and usage patterns of the Study IP, as well as use of any other TNPs, recorded in a daily survey. On completion of the last day of the HUT, participants will complete a final end of study survey assessing product liking, purchase intent, and intended use behaviors.
To account for respondent drop-out, the fieldwork team will recruit approximately 15% more participants for the CLT and approximately 20% more participants to the HUT phase.
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: RDTH002581, Other: RDTH002580, Other: RDTH002582Participants will be randomized to one of three stick variants. |
| HTP Device (2) | Experimental | Other: RDTH002578, Other: RDTH002577, Other: RDTH002579Participants will be randomized to one of three stick variants. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged 21-65 years (inclusive)
- Be self-reported current 'daily users' of at least 5 CPD and have smoked at least 100 cigarettes in their lifetime. ('daily users' defined as have smoked 5 CPD for at least 27 days out of last 30 days)
- 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.
Key exclusion criteria (18 listed)
- Women who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next three months from the study start date.
- Women who self-report they are not using adequate methods to prevent pregnancy, which they intend to continue throughout the study.
- People who self- report having pacemakers or other embedded electronic medical devices.
- People who self-report having heart disease, high blood pressure, diabetes, depression, or asthma.
- People who have ever used HTP.
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 |
|---|---|---|
| RDTH002581Participants assigned to this Study Intervention will use the product only in the CLT portion of the study. | Other | HTP Device (1) |
| RDTH002580Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study. | Other | HTP Device (1) |
| RDTH002582Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study. | Other | HTP Device (1) |
| RDTH002578Participants assigned to this Study Intervention will use the product only in the CLT portion of the study. | Other | HTP Device (2) |
| RDTH002577Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study. | Other | HTP Device (2) |
| RDTH002579Participants assigned to this Study Intervention will use the product in the CLT and HUT portions of the study. | Other | HTP Device (2) |
Primary outcome
To measure the puffing topography of primary combustible cigarette smokers when using either of the investigational HTP devices with one of three stick variants during CLT.
Time frame: 90 minutes
The primary endpoints will be measured in CLT using a desktop PA1. The data will be summarized using the overall mean per study arm (Study IP device) as well as mean per stick variant within arms.
4 secondary outcomes
To determine the average daily consumption of sticks during HUT.
Time frame: 5 days
To assess purchase intent for participants using each of the study products before and after using the products.
Time frame: Through study completion
To describe subjective characteristics associated with product use, including overall liking
Time frame: At study completion
To assess risk perceptions before using the products only.
Time frame: Baseline
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 23 Dec 2025.
- 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. This study is not recruiting at the moment.
Melissa Tapia, Ph.D. study director
RAI Services Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RDTH002581, RDTH002580 and RDTH002582 in people with Smoking Cigarette, run by RAI Services Company at 1 site 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 4 inclusion and 18 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
To measure the puffing topography of primary combustible cigarette smokers when using either of the investigational HTP devices with one of three stick variants during CLT. (time frame: 90 minutes). 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 23 Dec 2025.