An interventional study of FT25614 and FT25615 in Smoking and Tobacco, sponsored by RAI Services Company. Recruiting at 5 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other
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.
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's planned enrollment of 480 is above the median of 117 across 250 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:
Participants in the study are allowed to self-select from the following three IP flavor options.
Other: FT25614 · Other: FT25615 · Other: FT25616
Tobacco SKU #1
Tobacco SKU #2
Tobacco SKU #3
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.
Time frame: 13 weeks
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
Time frame: 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.
Time frame: 13 weeks
Topography
Puffing topography, quit attempts, descriptives of Study IP liking, intent to substitute CCs with Study IP, and intent to purchase will be summarized numerically.
Time frame: 13 Weeks
Demographics
Demographic characteristics of the study population will be tabulated and summarized numerically.
Time frame: 13 Weeks
AEs
The study will monitor any adverse events/experiences among participants using the Study IP.
Time frame: 13 Weeks
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 155 interventional studies with no phase under Smoking, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 59. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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