SmokingNCT07710820
A Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers
A study testing 31237616, 31237617 and 31237571 in people with Smoking and Tobacco, run by RAI Services Company at 9 sites in United States.
Trial summary
The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- What is being tested?
- 31237616, 31237617 and 31237571
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2026to Dec 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
- Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent, verified with government-issued identification.
- All female (assigned at birth) candidate participants 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
- Currently smoke at least five combustible cigarettes on smoking days in the past 30 days.
- Smoke combustible cigarettes on 15 or more of the past 30 days.
- Smoked at least 100 factory-made filtered menthol and/or non-menthol combustible cigarettes in their lifetime prior to the Site Enrollment Visit.
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- Must indicate a neutral/positive intention to use at least one stick variant at the Site Enrollment Visit.
- Own a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.
- Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.
- Must try all four stick variants during the 1-week product trial period.
- Must indicate a neutral/positive intention to use at least one stick variant following the product trial period.
Who cannot join
- Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
- Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the time of the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Female participants who self-report not using adequate methods to prevent pregnancy.
- Persons with pacemakers or other embedded electronic medical devices fitted.
- Participants who self-report having an unstable heart condition, severe hypertension, or diabetes.
- Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.
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- Participants who have used electronic nicotine delivery system (ENDS), nicotine pouches, HTP or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, other combustible tobacco/nicotine products, and other oral nicotine products (tablets, gums, and lozenges) on 5 or more days in the past 30 days.
- Participants 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.
- Employee of a company that manufactures tobacco or HTPs.
- Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or HTPs.
- Have taken part in a tobacco/nicotine research study in the past 30 days.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Opinions Chicago
Aurora, Illinois, 60504
- Recruiting
Opinions Brandon
Brandon, Florida, 33511
- Recruiting
Opinions Coral Springs
Coral Springs, Florida, 33071
- Recruiting
Opinions Fort Worth
Fort Worth, Texas, 76132
- Recruiting
Opinions Chicago
Gurnee, Illinois, 60031
- Recruiting
Opinions Houston
Houston, Texas, 77070
- Recruiting
Opinions Dallas
Hurst, Texas, 76053
- Recruiting
Opinions Las Vegas
Las Vegas, Nevada, 89107
- Recruiting
Opinions Las Vegas
Las Vegas, Nevada, 89119
About this study
Official title: A Multi-Site Two-Arm Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Combustible Cigarette Smokers
The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). The primary study objective is to evaluate the impact of access to HTP Device 1 or HTP Device 2 and a single stick variant on the rate of final 7-day abstinence from smoking cigarettes among U.S. adult smokers at the end of a 3-month study period.
Read the detailed description
This will be a multi-site, open-label, two-arm study to evaluate the rate of end of study complete combustible cigarette (CC) reduction in healthy adult consumers of CC when given access to a heated tobacco product (HTP) device (glo or glo plus), with one of four variants of HTP consumables (also known as "sticks" or "stick variants", under the brand name "virto") over a 3-month (90-day) actual use period (AUP).
- Being tested
- 31237616, 31237617, 31237571, 31237581
- Keywords
- Tobacco Harm Reduction, Smoking, Tobacco Use, Tobacco Smoking
- Medical subject headings
- Smoking, Tobacco Use, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31237616Other
Tobacco Flavor #1
31237617Other
Tobacco Flavor #2
31237571Other
Menthol #1
31237581Other
Menthol #2
| Study group | Role | What they receive |
|---|---|---|
| HTP Device 1 | Active comparator | HTP Device (One Piece) with two menthol and two tobacco stick variants Receives: Other: 31237616; Other: 31237617; Other: 31237571; Other: 31237581 |
| HTP Device 2 | Active comparator | HTP Device (Two Piece) with two menthol and two tobacco stick variants Receives: Other: 31237616; Other: 31237617; Other: 31237571; Other: 31237581 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm.
Measured: 7 days
Secondary outcomes (5)
The number and proportion of participants who completely switch from combustible cigarette smoking to HTP device 1 or HTP device 2 during the entire final 7 days of the 3 month study period in each study arm and by stick variant within the study arm.
Measured: 7 days
The number and proportion of participants who reduce their combustible cigarettes by more than or equal to 50% within their average weekly cigarettes per day from baseline to final 7 days of the study period in each study arm and by stick variant.
Measured: 3 months
The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm
Measured: 3 months
The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm
Measured: 3 months
The number and type of adverse experiences/events in relation to use of the Study IP in each study arm and by stick variant within each study arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710820
- Sponsor's protocol ID
- PHI252504
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Two-Arm Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Combustible Cigarette Smokers
- ClinicalTrials.gov ID
- NCT07710820
- Acronym / sponsor ID
- PHI252504
- Keywords
- Tobacco Harm Reduction, Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 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.
The goal of this study is to evaluate the rate of end of study complete cigarette reduction in health adult consumers of cigarettes when given access to a heated tobacco product (HTP). The primary study objective is to evaluate the impact of access to HTP Device 1 or HTP Device 2 and a single stick variant on the rate of final 7-day abstinence from smoking cigarettes among U.S. adult smokers at the end of a 3-month study period.
Detailed description
This will be a multi-site, open-label, two-arm study to evaluate the rate of end of study complete combustible cigarette (CC) reduction in healthy adult consumers of CC when given access to a heated tobacco product (HTP) device (glo or glo plus), with one of four variants of HTP consumables (also known as "sticks" or "stick variants", under the brand name "virto") over a 3-month (90-day) actual use period (AUP).
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 | Active comparator | Other: 31237616, Other: 31237617, Other: 31237571, Other: 31237581HTP Device (One Piece) with two menthol and two tobacco stick variants |
| HTP Device 2 | Active comparator | Other: 31237616, Other: 31237617, Other: 31237571, Other: 31237581HTP Device (Two Piece) with two menthol and two tobacco stick variants |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent, verified with government-issued identification.
- All female (assigned at birth) candidate participants 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. Note: Participants who identify as "intersex" or "unknown" during screening, will be required to take a pregnancy test if they wish to take one.
- Currently smoke at least five combustible cigarettes on smoking days in the past 30 days.
- Smoke combustible cigarettes on 15 or more of the past 30 days.
Key exclusion criteria (11 listed)
- Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
- Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the time of the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
- Female participants who self-report not using adequate methods to prevent pregnancy.
- Persons with pacemakers or other embedded electronic medical devices fitted.
- Participants 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 |
|---|---|---|
| 31237616Tobacco Flavor #1 | Other | HTP Device 1, HTP Device 2 |
| 31237617Tobacco Flavor #2 | Other | HTP Device 1, HTP Device 2 |
| 31237571Menthol #1 | Other | HTP Device 1, HTP Device 2 |
| 31237581Menthol #2 | Other | HTP Device 1, HTP Device 2 |
Primary outcome
Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm.
Time frame: 7 days
5 secondary outcomes
The number and proportion of participants who completely switch from combustible cigarette smoking to HTP device 1 or HTP device 2 during the entire final 7 days of the 3 month study period in each study arm and by stick variant within the study arm.
Time frame: 7 days
The number and proportion of participants who reduce their combustible cigarettes by more than or equal to 50% within their average weekly cigarettes per day from baseline to final 7 days of the study period in each study arm and by stick variant.
Time frame: 3 months
The time to first 7-day abstinence of combustible cigarettes by participants in each study arm and by stick variant within each study arm
Time frame: 3 months
The weekly mean percent cigarettes per day reductions from baseline in each study arm and by stick variant within each arm
Time frame: 3 months
The number and type of adverse experiences/events in relation to use of the Study IP in each study arm and by stick variant within each study arm
Time frame: 3 months
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 17 Jul 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 31237616, 31237617 and 31237571 in people with Smoking and Tobacco, run by RAI Services Company at 9 sites in United States.
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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 Emily Smith (336-741-2396, smithe13@rjrt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and proportion of participants self-reporting past 7-day complete combustible cigarette reduction (abstinence) during the final 7 days of the 3-month (90-day) study period in each study arm and by stick variant within the study arm. (time frame: 7 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 17 Jul 2026.