An interventional study of 31237616 and 31237617 in Smoking and Tobacco, sponsored by RAI Services Company. Recruiting at 9 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other
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.
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).
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 1,060 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.
HTP Device (One Piece) with two menthol and two tobacco stick variants
Other: 31237616 · Other: 31237617 · Other: 31237571 · Other: 31237581
HTP Device (Two Piece) with two menthol and two tobacco stick variants
Other: 31237616 · Other: 31237617 · Other: 31237571 · Other: 31237581
Tobacco Flavor #1
Tobacco Flavor #2
Menthol #1
Menthol #2
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
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
Plan to share: No
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