Smoking BehaviorsNCT07881848
A Study to Assess Nicotine Uptake From a Menthol Electronic Nicotine Delivery System Product
A study testing Menthol 5% and Combustible cigarette in people with Smoking Behaviors and Smoking ( Cigarette), run by RAI Services Company.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors, Smoking ( Cigarette), Tobacco Use
- What is being tested?
- Menthol 5% and Combustible cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day -1.
- Weight of ≤ 110 pounds (≤ 50.0 kg) at Screening.
- Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at Screening.
- Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at an investigator's discretion.
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- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
- Must not be a current regular user (i.e., > 5 times per month) of any tobacco products other than menthol cigarettes or ENDS within the last 6 months prior to screening.
- Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.
- History or presence of bleeding or clotting disorders.
- Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.
- 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.
- Participation in another clinical trial within ≤ 30 days prior to the signing of informed consent. The 30-day window for each participant will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
- Females who have a positive pregnancy test at Screening or check-in on Day -1, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
- A positive drug screen or alcohol test (urine or breath) at Screening or at check-in (Day -1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in, a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of an investigator.
- Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within ≤ 30 days prior to the signing of the ICF.
- Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by an investigator, or has a positive alcohol test at Screening or check-in on Day -1.
- Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
- Individuals or their family members that have ongoing litigation with tobacco company(ies).
- Determined by an investigator to be inappropriate for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Randomized, 2-way Crossover Study to Assess Elements of Abuse Liability of Electronic Nicotine Delivery System (ENDS) Product in Exclusive Menthol Cigarette Smokers and Dual Users of Menthol Cigarettes and ENDS Products
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.
Read the detailed description
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.
- Conditions
- Smoking Behaviors, Smoking ( Cigarette), Tobacco Use, Abuse Liability
- Being tested
- Menthol 5%, Combustible cigarette
- Medical subject headings
- Smoking, Cigarette Smoking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol 5%Other
Menthol ENDS 5%
Combustible cigaretteOther
Usual brand filtered menthol combustible cigarette
| Study group | Role | What they receive |
|---|---|---|
| Product usage order AB | Experimental | Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Menthol 5%; Other: Combustible cigarette |
| Product usage order BA | Experimental | Subjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Menthol 5%; Other: Combustible cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 minutes to 240 minutes
Emax PL
maximum PL VAS score after the start of IP use
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAI Services Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milly Kanobe, Study director, Reynolds American
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881848
- Sponsor's protocol ID
- IHI260201
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-way Crossover Study to Assess Elements of Abuse Liability of Electronic Nicotine Delivery System (ENDS) Product in Exclusive Menthol Cigarette Smokers and Dual Users of Menthol Cigarettes and ENDS Products
- ClinicalTrials.gov ID
- NCT07881848
- Acronym / sponsor ID
- IHI260201
- Conditions
- Smoking Behaviors, Smoking ( Cigarette), Tobacco Use, Abuse Liability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product usage order AB | Experimental | Other: Menthol 5%, Other: Combustible cigaretteSubjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order BA | Experimental | Other: Menthol 5%, Other: Combustible cigaretteSubjects will use each of the 2 products during an evaluation period, followed by a 4 hour Test Session. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.
- History, presence of, or clinical laboratory test results indicating diabetes.
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day -1.
- Weight of ≤ 110 pounds (≤ 50.0 kg) at Screening.
- Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at Screening.
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 |
|---|---|---|
| Menthol 5%Menthol ENDS 5% | Other | Product usage order AB, Product usage order BA |
| Combustible cigaretteUsual brand filtered menthol combustible cigarette | Other | Product usage order AB, Product usage order BA |
Primary outcome
AUC nic 3-240
Time frame: 3 minutes to 240 minutes
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time 3 to 240 minutes after the start of IP use
Emax PL
Time frame: 240 minutes
maximum PL VAS score after the start of IP use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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.
Milly Kanobe study director
Reynolds American
Questions about this trial
What is this clinical trial studying?
A study testing Menthol 5% and Combustible cigarette in people with Smoking Behaviors and Smoking ( Cigarette), run by RAI Services Company.
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 0 inclusion and 25 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Smith (3367412396, smithe13@rjrt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC nic 3-240 (time frame: 3 minutes to 240 minutes). The study lists 2 primary outcomes in all. 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 20 Oct 2026.