SmokingNCT07172438
A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers
A study testing P2611222, P2615022 and P2615122 in people with Smoking and Tobacco, run by RAI Services Company at 27 sites in United States.
Trial summary
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- What is being tested?
- P2611222, P2615022 and P2615122
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 27 sitesUnited States
- Study dates
- 17 Sep 2025to 14 Jan 2026
- 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
- 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) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, 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 offered the opportunity to receive a pregnancy test if they wish to take one.
- Currently smoke at least 10 cigarettes on smoking days in the past 30 days
- Smoke cigarettes regularly for at least 12 months
Show all 11Show fewer
- Smoke cigarettes on 15 or more of the past 30 days
- Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit.
- Must indicate smoking factory-made filtered menthol and/or non-menthol cigarettes as their primary nicotine product (Occasional use of other tobacco- or nicotine-containing products is acceptable)
- Indicate a willingness to use ENDS
- Agree to participate in the study and to abide by the study restrictions and requirements, as described in the informed concent form (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.
- Female participants who self-report not using adequate methods to prevent pregnancy
- Persons with pacemakers or other embedded electronic medical devices fitted
- Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression.
- Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below:
- Carvone (L-)
Show all 13Show fewer
- Benzyl alcohol
- Participants who have used ENDS, nicotine pouch or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products on 5 or more days in the past 30 days
- Participants who have used ENDS, nicotine pouch or smokeless tobacco products more than 100 times in their lifetime
- 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 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
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Research America Orlando
Altamonte Springs, Florida, 32701
C&C-Arlington
Arlington, Texas, 76015
CRG Test America-Phoenix
Chandler, Arizona, 85226
CRG Test America-St. Peters
City of Saint Peters, Missouri, 63376
C&C-Tampa
Clearwater, Florida, 33761
Sago Dallas
Dallas, Texas, 75254
C&C-Fort Smith
Fort Smith, Arkansas, 72908
CRG Test America-Grapevine
Grapevine, Texas, 76051
Sago Houston
Houston, Texas, 77027
C&C-Humble
Humble, Texas, 77338
Southern Solutions Knoxville
Knoxville, Tennessee, 37922
C&C-Lombard
Lombard, Illinois, 60148
Sago Orlando
Maitland, Florida, 32751
C&C-Mesquite
Mesquite, Texas, 75150
CRG Test America-Pembroke Pines
Miami, Florida, 33026
CRG Test America-Ormond Beach
Ormond Beach, Florida, 32174
Sago Philadelphia
Philadelphia, Pennsylvania, 19103
C&C-Philadelphia
Philadelphia, Pennsylvania, 19154
C&C-Plantation
Plantation, Florida, 33388
C&C-San Antonio
San Antonio, Texas, 78216
C&C-San Antonio
San Antonio, Texas, 78224
C&C-Sebring
Sebring, Florida, 33870
C&C-Richmond Heights
St Louis, Missouri, 63117
Sago St. Louis
St Louis, Missouri, 63131
C&C-Tallahassee
Tallahassee, Florida, 32301
CRG Test America-Tampa
Tampa, Florida, 33609
C&C-Troy
Troy, Michigan, 48083
About this study
Official title: A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers.
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
Read the detailed description
This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end-of-study abstinence of healthy adult consumers of combustible cigarettes when provided an electronic nicotine delivery system over a three-month (ninety-day) ambulatory study period.
Potential participants will be recruited and enrolled at 27 sites across the United States. Ipsos will recruit participants in person (e.g., through mall intercepts) at each site or by telephone from existing databases of previous research participants. Based on meeting eligibility requirements, participants will be required to read and sign an Informed Consent Form and to attend a site visit to complete enrollment.
At the Enrollment Visit, participants will be randomized to one of the three study arms. All participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their assigned study arm.
All participants will attend mandatory follow-up site visits on Day 0, Day 30, Day 60, and Day 90, with the option of changing to a different flavor among the available flavors based upon their assigned study arm, if applicable. In the first four weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits on Day 7, Day 14, and Day 21, with the option of changing flavors among those available in their assigned study arm. All site visits will record the number of study investigational product cartridges dispensed, in addition to all used and unused investigational product cartridges returned.
During the three-month ambulatory study period, participants will be free to use the study investigational product and any other tobacco or nicotine products as desired. The electronic nicotine delivery system (Version 2) power unit technology will measure their puffing topography during use (including puff duration and the time interval between puffs). The puffing topography data will be automatically transferred to a secure online database via a Bluetooth transfer application using the provided smartphone.
Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on the provided smartphone. Surveys will collect data on:
- The number of cigarettes smoked the previous day
- Current flavor use
- Product liking
- Number of cigarette quit attempts
- Use of other tobacco or nicotine products
- Intent to substitute their usual brand combustible cigarettes for the study investigational product (e.g., gradual, complete, or future intent)
- Social and environmental factors influencing switching intent
At the conclusion of the ambulatory study period, all participants will return to the study sites for a close-out period and will then be discharged from the study.
- Being tested
- P2611222, P2615022, P2615122, P2613422
- 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.
P2611222Other
Menthol flavor
P2615022Other
Non-tobacco non-menthol flavor
P2615122Other
Non-tobacco non-menthol flavor
P2613422Other
Tobacco flavor
| Study group | Role | What they receive |
|---|---|---|
| Tobacco, Menthol, Non Tobacco Non Menthol Flavors | Active comparator | Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%). Receives: Other: P2611222; Other: P2615022; Other: P2615122; Other: P2613422 |
| Tobacco and Menthol Flavor | Active comparator | Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%). Receives: Other: P2611222; Other: P2613422 |
| Tobacco Flavor | Active comparator | Participants can use a tobacco flavor variant at one nicotine level (5%). Receives: Other: P2613422 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
The odds (i.e., relative probabilities) of participants self-reporting 7-day point prevalence abstinence from combustible cigarette (CC) smoking, as recorded in an electronic diary (eDiary) during the final 7 days of the 13-week study period, comparing Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3.
Measured: 13-weeks
Secondary outcomes (6)
Odds of final 7-day abstinence between each of the preferred flavor groups (Study Arms 1 and 2).
Odds of self-reported final 7-day point prevalence abstinence from combustible cigarette smoking between preferred flavor groups (Study Arms 1 and 2), assessed via electronic diary (eDiary)
Measured: 13-weeks
Odds rate of final 7-day complete switching between each of the preferred flavor groups (Study Arms 1 and 2 only).
Measured: 13-weeks
Time to first 7-day abstinence by Study Arm.
Measured: 13-weeks
Time to first 7-day abstinence by preferred flavor group.
Measured: 13-weeks
Weekly mean percent cigarettes per day reductions from baseline by Study Arm and preferred flavor group.
Measured: 13-weeks
Odds of 50% average weekly cigarettes per day reduction from baseline to final 7-days of study between Study Arm 1 and Study Arm 3, and between Study Arm 2 and Study Arm 3.
Odds of achieving ≥50% reduction in average self-reported cigarettes per day (CPD) from baseline to final 7 days of the study, based on daily entries in an electronic diary (eDiary), comparing Study Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3
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 posted15 Sep 2025
- Study start17 Sep 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Why it stopped: The study was terminated due to data integrity concerns that affected the ability to reliably assess the study endpoints.
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.
- More trials run by RAI Services CompanyThe sponsor's other registered studies.
- 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
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Tapia, Ph.D., Study director, RAIS Service Co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172438
- Sponsor's protocol ID
- PHCB3US20256
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2025
- Last updated
- 27 Feb 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers.
- ClinicalTrials.gov ID
- NCT07172438
- Acronym / sponsor ID
- PHCB3US20256
- Keywords
- Tobacco Harm Reduction, Smoking, Tobacco Use, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to data integrity concerns that affected the ability to reliably assess the study endpoints.
- Enrolment
- 668 participants (actual)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 15 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.
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
Detailed description
This will be a multi-site, open-label, randomized controlled trial to evaluate the rate of end-of-study abstinence of healthy adult consumers of combustible cigarettes when provided an electronic nicotine delivery system over a three-month (ninety-day) ambulatory study period.
Potential participants will be recruited and enrolled at 27 sites across the United States. Ipsos will recruit participants in person (e.g., through mall intercepts) at each site or by telephone from existing databases of previous research participants. Based on meeting eligibility requirements, participants will be required to read and sign an Informed Consent Form and to attend a site visit to complete enrollment.
At the Enrollment Visit, participants will be randomized to one of the three study arms. All participants will begin the study with a one-week Trial Period. This Trial Period will allow participants to sample the available flavor(s) within their assigned study arm.
All participants will attend mandatory follow-up site visits on Day 0, Day 30, Day 60, and Day 90, with the option of changing to a different flavor among the available flavors based upon their assigned study arm, if applicable. In the first four weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits on Day 7, Day 14, and Day 21, with the option of changing flavors among those available in their assigned study arm. All site visits will record the number of study investigational product cartridges dispensed, in addition to all used and unused investigational product cartridges returned.
During the three-month ambulatory study period, participants will be free to use the study investigational product and any other tobacco or nicotine products as desired. The electronic nicotine delivery system (Version 2) power unit technology will measure their puffing topography during use (including puff duration and the time interval between puffs). The puffing topography data will be automatically transferred to a secure online database via a Bluetooth transfer application using the provided smartphone.
Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on the provided smartphone. Surveys will collect data on:
- The number of cigarettes smoked the previous day
- Current flavor use
- Product liking
- Number of cigarette quit attempts
- Use of other tobacco or nicotine products
- Intent to substitute their usual brand combustible cigarettes for the study investigational product (e.g., gradual, complete, or future intent)
- Social and environmental factors influencing switching intent
At the conclusion of the ambulatory study period, all participants will return to the study sites for a close-out period and will then be discharged from the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tobacco, Menthol, Non Tobacco Non Menthol Flavors | Active comparator | Other: P2611222, Other: P2615022, Other: P2615122, Other: P2613422Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%). |
| Tobacco and Menthol Flavor | Active comparator | Other: P2611222, Other: P2613422Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%). |
| Tobacco Flavor | Active comparator | Other: P2613422Participants can use a tobacco flavor variant at one nicotine level (5%). |
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
- All female (assigned at birth) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, 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 offered the opportunity to receive a pregnancy test if they wish to take one.
- Currently smoke at least 10 cigarettes on smoking days in 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.
- Female participants who self-report not using adequate methods to prevent pregnancy
- Persons with pacemakers or other embedded electronic medical devices fitted
- Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression.
- Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below:
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 |
|---|---|---|
| P2611222Menthol flavor | Other | Tobacco and Menthol Flavor, Tobacco, Menthol, Non Tobacco Non Menthol Flavors |
| P2615022Non-tobacco non-menthol flavor | Other | Tobacco, Menthol, Non Tobacco Non Menthol Flavors |
| P2615122Non-tobacco non-menthol flavor | Other | Tobacco, Menthol, Non Tobacco Non Menthol Flavors |
| P2613422Tobacco flavor | Other | Tobacco Flavor, Tobacco and Menthol Flavor, Tobacco, Menthol, Non Tobacco Non Menthol Flavors |
Primary outcome
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
Time frame: 13-weeks
The odds (i.e., relative probabilities) of participants self-reporting 7-day point prevalence abstinence from combustible cigarette (CC) smoking, as recorded in an electronic diary (eDiary) during the final 7 days of the 13-week study period, comparing Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3.
6 secondary outcomes
Odds of final 7-day abstinence between each of the preferred flavor groups (Study Arms 1 and 2).
Time frame: 13-weeks
Odds rate of final 7-day complete switching between each of the preferred flavor groups (Study Arms 1 and 2 only).
Time frame: 13-weeks
Time to first 7-day abstinence by Study Arm.
Time frame: 13-weeks
Time to first 7-day abstinence by preferred flavor group.
Time frame: 13-weeks
Weekly mean percent cigarettes per day reductions from baseline by Study Arm and preferred flavor group.
Time frame: 13-weeks
Odds of 50% average weekly cigarettes per day reduction from baseline to final 7-days of study between Study Arm 1 and Study Arm 3, and between Study Arm 2 and Study Arm 3.
Time frame: 13-weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to data integrity concerns that affected the ability to reliably assess the study endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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. This study is not recruiting at the moment.
Melissa Tapia, Ph.D. study director
RAIS Service Co
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P2611222, P2615022 and P2615122 in people with Smoking and Tobacco, run by RAI Services Company at 27 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 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: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
The study was stopped early (reason given: The study was terminated due to data integrity concerns that affected the ability to reliably assess the study endpoints.). Results are not available in the source record.
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?
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period (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 27 Feb 2026.