SmokingNCT07879638
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
A study testing FT25614, FT25615 and FT25616 in people with Smoking and Tobacco, run by RAI Services Company at 5 sites in United States.
Trial summary
This is a multi-site, open-label, single arm study to evaluate the rate of smoking abstinence by the end of the study with healthy adult consumers of cigarettes when provided with an e-cigarette over a 13 week study period. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- What is being tested?
- FT25614, FT25615 and FT25616
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Sep 2026to Mar 2027
- 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.
- All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at SEV that they are not pregnant or intending to become pregnant.
- Currently smoke at least 5 CC on smoking days in the past 30 days.
- Smoke CC on 15 or more of the past 30 days.
- Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
Show all 9Show fewer
- Indicate a willingness to use ENDS.
- Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications or be willing to use a study-provided phone for surveys and other required study activities.
- Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.
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.
- Persons who self-report they are allergic/sensitive to cosmetics or fragrances or any ingredient listed in commercial e-cigarette products.
Show all 13Show fewer
- Participants who self-report poor physical or mental health.
- Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, or other combustible products and other oral nicotine products (tablets, gums, lozenges) on 11 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.
- Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
- Employee of a company that manufactures tobacco or ENDS products.
- Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
- Have taken part in a tobacco/nicotine research study in the past 30 days.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Sago Atlanta
Atlanta, Georgia, 30328
- Recruiting
Sago Chicago
Chicago, Illinois, 60611
- Recruiting
Sago Dallas
Dallas, Texas, 75254
- Recruiting
MARS Research
Fort Lauderdale, Florida, 33309
- Recruiting
Sago New Jersey
Iselin, New Jersey, 08830
About this study
Official title: An Extension Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Combustible Cigarette Smokers Using an Electronic Nicotine Delivery System, With Comparison to a Single Tobacco Flavor Comparator Arm From an Earlier Randomized Controlled Trial
This is a multi-site, open-label, single arm study to evaluate the rate of smoking abstinence by the end of the study with healthy adult consumers of cigarettes when provided with an e-cigarette over a 13 week study period.
Read the detailed description
This will be a multi-site, open-label, single-arm study to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) with a choice of multiple tobacco flavors over a 13-week study period. Outcomes from this study will be compared with those from a single tobacco-flavor comparator arm from an earlier conducted randomized controlled trial (RCT) with a similar design.
- Being tested
- FT25614, FT25615, FT25616
- 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.
FT25614Other
Tobacco SKU #1
FT25615Other
Tobacco SKU #2
FT25616Other
Tobacco SKU #3
| Study group | Role | What they receive |
|---|---|---|
| Self Selection Arm | Experimental | Participants in the study are allowed to self-select from the following three IP flavor options. Receives: Other: FT25614; Other: FT25615; Other: FT25616 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of varying levels of access to tobacco flavor options
To evaluate the impact of varying levels of access to Vuse ENDS tobacco flavor options on the rate of final 7-day abstinence from smoking CC among U.S. adult smokers at the end of a 13-week intervention period.
The rate of final 7-day abstinence among participants with access to multiple tobacco flavor options in this study will be compared to the rate of final 7-day abstinence in the single tobacco flavor comparator arm in an RCT conducted earlier.
Measured: 13 weeks
Secondary outcomes (2)
Complete Switching
Analyses of complete switching (defined as being abstinent from smoking CCs as well as being an adopted user of the Study IP) between participants in this study with access to multiple tobacco flavors and the single tobacco flavor comparator arm from a RCT conducted earlier, as well as between preferred flavor groups
Measured: 13 weeks
Abstinence Between Flavor Groups
Additional analyses will evaluate abstinence between preferred flavor groups; time to first 7-day abstinence between this study and the single tobacco flavor comparator arm from the prior study, and between preferred flavor groups within this study; reductions in CPD from baseline to end of study; and ≥50% CPD reductions between this study and the single tobacco flavor comparator arm in an RCT conducted earlier.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start30 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Tapia, Study director, RAIS Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879638
- Sponsor's protocol ID
- PHI262611
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Combustible Cigarette Smokers Using an Electronic Nicotine Delivery System, With Comparison to a Single Tobacco Flavor Comparator Arm From an Earlier Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07879638
- Acronym / sponsor ID
- PHI262611
- Keywords
- Tobacco Harm Reduction, Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Oct 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 multi-site, open-label, single arm study to evaluate the rate of smoking abstinence by the end of the study with healthy adult consumers of cigarettes when provided with an e-cigarette over a 13 week study period.
Detailed description
This will be a multi-site, open-label, single-arm study to evaluate the rate of end of study (EOS) smoking abstinence of healthy adult consumers of combustible cigarettes (CC) when provided an electronic nicotine delivery system (ENDS) with a choice of multiple tobacco flavors over a 13-week study period. Outcomes from this study will be compared with those from a single tobacco-flavor comparator arm from an earlier conducted randomized controlled trial (RCT) with a similar design.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self Selection Arm | Experimental | Other: FT25614, Other: FT25615, Other: FT25616Participants in the study are allowed to self-select from the following three IP flavor options. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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.
- All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at SEV that they are not pregnant or intending to become pregnant.
- Currently smoke at least 5 CC on smoking days in the past 30 days.
- Smoke CC on 15 or more of the past 30 days.
Key exclusion criteria (13 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 |
|---|---|---|
| FT25614Tobacco SKU #1 | Other | Self Selection Arm |
| FT25615Tobacco SKU #2 | Other | Self Selection Arm |
| FT25616Tobacco SKU #3 | Other | Self Selection Arm |
Primary outcome
Impact of varying levels of access to tobacco flavor options
Time frame: 13 weeks
To evaluate the impact of varying levels of access to Vuse ENDS tobacco flavor options on the rate of final 7-day abstinence from smoking CC among U.S. adult smokers at the end of a 13-week intervention period. The rate of final 7-day abstinence among participants with access to multiple tobacco flavor options in this study will be compared to the rate of final 7-day abstinence in the single tobacco flavor comparator arm in an RCT conducted earlier.
2 secondary outcomes
Complete Switching
Time frame: 13 weeks
Abstinence Between Flavor Groups
Time frame: 13 weeks
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 22 Oct 2026.
Related trials for Smoking
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
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 study director
RAIS Company
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT25614, FT25615 and FT25616 in people with Smoking and Tobacco, run by RAI Services Company at 5 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 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Impact of varying levels of access to tobacco flavor options (time frame: 13 weeks). 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 22 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.