An interventional study of Menthol 5% and Combustible cigarette in Smoking Behaviors, Smoking ( Cigarette) and Tobacco Use, sponsored by RAI Services Company. Not yet recruiting. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other
This will be a randomized, open-label, 2-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine uptake (pharmacokinetics [PK]) of Menthol ENDS investigational product (IP) relative to each participant's usual brand (UB) menthol cigarette. The study will be conducted in a confinement setting in generally healthy adult menthol cigarette smokers and dual users of menthol cigarettes and ENDS products.
Current adult menthol cigarette smokers and dual users of menthol cigarettes and ENDS will be recruited into this study to evaluate elements of AL of the Menthol ENDS, in comparison to participant's usual brand (UB) cigarette. The study design, including daily product use and test session schedule, is illustrated in Figure 1-1. A summary of study activities is provided below:
Potential participants will undergo a pre-screening interview followed by a Screening Visit within 28 days prior to enrollment, randomization, and study confinement to assess eligibility.
Eligible participants will be scheduled for a check-in and randomization visit. At this visit, eligibility will be reconfirmed prior to randomization to a product use sequence, based on a Williams design. Participants will then enter a 4-day, 3 night confinement period at the clinical site.
On study Day -1, participants will enter a product familiarization period during which they will be required to use the Menthol ENDS (Product B [Menthol 5%]) at least once. Use of the Menthol ENDS during the familiarization period will be approximately 5 minutes. After completing this familiarization, participants will be permitted to smoke their UB cigarettes ad libitum. Participants who also use other tobacco and/or nicotine-containing products such as ENDS, smokeless tobacco or modern oral nicotine products in addition to their UB cigarettes will not have access to those products during the study.
Following the product familiarization period, participants will enter a product acclimation period beginning on Day 1 and each day prior to a test session. During each daily product acclimation period, participants will be required to use their randomized Menthol ENDS assigned for use in the subsequent day's test session (no product acclimation for UB cigarette) at least four times. For the Menthol ENDS, product use period during the daily acclimation period will last approximately 5 minutes. After completing this requirement, participants will be permitted to smoke their UB cigarettes ad libitum. Pharmacy logs will be used to capture information on product usage during the product familiarization and acclimation periods.
At the end of the product acclimation period and ad libitum use of the participant's UB cigarette, participants will abstain from use of all tobacco- and nicotine-containing products for a minimum of 12 hours prior to each test session, occurring on the following day. In addition, participants will be required to abstain from any caffeine-containing products for 4 hours prior to the start of each test session through the end of the test session.
Starting on Day 2 and continuing through Day 3, each participant will participate in two consecutive daily test sessions, evaluating one study product per session. Over the course of the study, each participant will evaluate a total of two products: one Menthol ENDS and a high-AL comparator (the participant's UB cigarette).
During each test session, subjective effects questionnaire responses will be collected before, during, and after each product use. Blood samples will then be collected for plasma nicotine PK assessments, and, subsequently, the collection of physiological measures after the assigned product use.
The active period of each test session will start with the assigned product use initiation and last approximately 4 hours during and following product use. During each test session, participants will smoke one UB menthol cigarette or use the Menthol ENDS ad libitum for approximately 5 minutes, based on the product use sequence to which participants will be randomized.
Participants' use of the Menthol ENDS will be self-defined during the 5-minute ad libitum IP use session; specific parameters around puff duration, volume, inter- puff interval, and quantity will not be prescribed.
Participant general health and well-being will be monitored throughout the study by the Principal Investigator (PI) or qualified designee by adverse events (AEs) assessments, vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. The Medical Monitor will be available for consultation throughout the study and for any necessary follow-up after discharge.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's planned enrollment of 28 is below 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.
Participants must meet one (a or b) of the following tobacco use conditions:
a. Sole smoker of filtered menthol cigarettes who self reports: i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of an investigator b. Dual user of cigarettes and ENDS who self-reports: i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of an investigator, and ii. Using a nicotine-containing ENDS (cartridge or a tank system). NOTE: Cigarette smokers or ENDS users who also use other tobacco- or nicotine-containing products (e.g., smokeless tobacco, and modern oral nicotine products) on no more than one day per week will not be excluded from study participation.
Females must be willing to use a form of contraception acceptable to an investigator from the time of signing informed consent until End-of-Study. Examples of acceptable means of birth control include, but are not limited to:
Exclusion Criteria:
Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day -1.
NOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.
Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and check-in Day -1.
NOTE: Participants will be advised against scheduling a plasma donation for at least 7 days following study completion.
Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session.
Other: Menthol 5% · Other: Combustible cigarette
Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session.
Other: Menthol 5% · Other: Combustible cigarette
Menthol ENDS 5%
Usual brand filtered menthol combustible cigarette
AUC nic 3-240
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time 3 to 240 minutes after the start of IP use
Time frame: 3 minutes to 240 minutes
Emax PL
maximum PL VAS score after the start of IP use
Time frame: 240 minutes
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
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 1 month 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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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