An interventional study of P2613422 and P2611222 in Smoking and Tobacco, sponsored by RAI Services Company. Recruiting at 7 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other
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, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.
This will be a multi-site, open-label, randomized controlled trial 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) over a 13-week study period.
Potential participants will be recruited and enrolled at multiple sites across the U.S. They will complete a pre-screening questionnaire to assess their study eligibility approximately 60 days prior to enrollment. Participants who meet pre-screening criteria will provide an informed consent to attend a screening and enrollment visit (SEV), which is a mandatory site visit (MSV) during which participants will be screened, and eligible participants will be randomized to one of the three study arms.
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 Study Arm.
All participants will attend MSV on Days 0, 30, 60, and 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 4-weeks of the study, participants in Study Arms 1 and 2 may also attend optional site visits (OSV) on Days 7, 14, and 21, with the option of changing flavors to a different flavor among the available flavors in their assigned Study Arm. During the 13-week study period, participants will be free to use the ENDS and any other tobacco or nicotine products as desired. The ENDS Version 2 Power Unit technology will measure their puffing topography during use (puff duration and inter-puff interval). Participants will be invited to complete daily, weekly, and monthly surveys, using a mobile application installed on their own smart phones. Surveys will collect data on the number of CC smoked the previous day, current flavor use, product liking, number of cigarette quit attempts, and any other tobacco or nicotine products used, intent to substitute their UB CC for the Study IP and social/environmental factors influencing switching intent. At the conclusion of the study period, all participants will return to the sites for a close out period and will be discharged from the study. Safety and adverse events/experiences (AEs) will be monitored throughout the study via a safety Hotline.
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 1,280 is above the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants can choose between tobacco and two non-tobacco/non-menthol/mint flavor variants at one nicotine level (5%).
Other: P2613422 · Other: P2615522 · Other: P2615122
Participants can choose between tobacco, mint, and menthol flavor variants at one nicotine level (5%).
Other: P2613422 · Other: P2611222 · Other: P2615422
Participants can use a tobacco flavor variant at one nicotine level (5%).
Other: P2613422
Tobacco Flavor
Menthol Flavor
Non-tobacco, Non-menthol/Mint Flavor
Non-tobacco, Non-menthol/Mint Flavor
Mint Flavor
Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period
The estimate of the risk ratio for self-reporting past 7-day abstinence from CC smoking during the final 7 days of the 13-week study period in (i) Study Arm 1 (tobacco and two NTNM flavors) versus Study Arm 3 (tobacco flavor only); and (ii) Study Arm 2 (tobacco, menthol, and mint flavors) versus Study Arm 3.
Time frame: 13 Weeks
Proportion of participants who completely switched during the final 7 days in Study Arm 1 vs. Study Arm 3 and Study Arm 2 vs. Study Arm 3.
The estimate of the proportion of participants who completely switched from CC smoking to Vuse ENDS during the entire final 7 days of the 13-week study period in Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3. Complete switching is defined as being abstinent from smoking CCs during the final 7-days of the study period, as well as being an adopter of Study IP (defined as ≥ 4 days of Study IP use \[verified by puff topography data\] for each week during the final two weeks of the study period).
Time frame: 13 weeks
Proportion of final 7-day complete switching between any of the preferred flavor groups (Study Arm 1 and 2).
Time frame: 13 weeks
Proportion of final 7-day abstinence between any of the preferred flavor groups (Study Arm 1 and 2)
"Preferred Flavor" to be defined in the statistical analysis plan (SAP), and each participant's preferred flavor will be used to assign them to their "preferred flavor group", which will be incorporated in subsequent analyses
Time frame: 13 weeks
Risk ratio of 50% reduction in average weekly CPD from baseline to final 7-days of study between Study Arm 1 and Study Arm 3 and Study Arm 2 and Study Arm 3.
Time frame: 13 weeks
Time to first 7-day abstinence by Study Arm and preferred flavor group
Time frame: 13 weeks
Weekly mean percent CPD reductions from baseline by Study Arm and preferred flavor group.
Time frame: 13 weeks
Safety profile of the study IP
An additional endpoint of critical importance is AEs per participant, which will be described in the tables, figures, and listings (TFLs) in addition to the final study report. No inferential testing is planned for AEs.
Time frame: 13 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.