Smoking BehaviorsNCT07739797
A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
A study testing Golden Tobacco Chill 5% (4) 6.5W, Glacier Menthol 5% (4) 6.5W and Fresh Mint 5% (4) 6.5W in people with Smoking Behaviors and Smoking ( Cigarette), run by RAI Services Company.
Trial summary
This will be a randomized, open-label, 8-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]) during and following ad libitum use of electronic nicotine… 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?
- Golden Tobacco Chill 5% (4) 6.5W, Glacier Menthol 5% (4) 6.5W and Fresh Mint 5% (4) 6.5W
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Apr 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
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.
- Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant.
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- Participants must meet one (a or b) of the following tobacco use conditions:
- Sole smoker of filtered menthol or non-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.
- Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes."
- Willing to use only UB cigarettes and ENDS IPs during the study period.
- Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session.
- 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:
- Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
- Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
- Non-hormone releasing intrauterine devices (IUDs) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
- Vasectomized partner;
- Post-menopausal and not on hormone replacement therapy; or
- Sexual abstinence, defined as refraining from intercourse, when this is in line with the preferred and usual lifestyle of the participant.
- Males must use an acceptable method of birth control from Day -1 "check-in" until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.
- Agrees to in-clinic confinement of 10 days and 9 nights.
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 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, 8-way Crossover Study to Assess Elements of Abuse Liability Electronic Nicotine Delivery System Products in Adult Smokers
This will be a randomized, open-label, 8-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]) during and following ad libitum use of electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Read the detailed description
Adult smokers of filtered menthol and/or non-menthol cigarettes and smokers who also use ENDS will be recruited into this study to evaluate elements of ENDS IP AL, in comparison to participant's usual brand (UB) cigarette.
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 10-day, 9-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 each of three ENDS IP (Product C [Glacier Menthol 5%, device, 6.5W], Product F [Fresh Mint 5%, device, 6.5W], and Product H [Fresh Mint 5%, device, 6.5W]) at least once. Use of each ENDS IP 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 IP assigned for use in the subsequent day's test session (excluding their UB cigarette) at least four times. For each ENDS IP, each 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 9, each participant will participate in eight consecutive daily test sessions, evaluating one IP per session. Over the course of the study, each participant will evaluate a total of eight IPs: seven ENDS IPs 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 IP use. Table 1-1 and Table 1-2 outline the schedule of study procedures, and the timing and sequence of activities involving behavioral questionnaires, PK blood sampling and physiological measurements, respectively.
The active period of each test session will start with the assigned IP use initiation and last approximately 4 hours during and following product use. During each test session, participants will be allowed approximately 5 minutes of smoking one UB cigarette and approximately 5 minutes of ENDS IP use based on the product use sequence to which participants will be randomized.
Participants' use of the ENDS IP 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.
ENDS IP e-liquid cartridges will be weighed within 4 hours before and after the test session on Days 2 - 9.
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
- Being tested
- Golden Tobacco Chill 5% (4) 6.5W, Glacier Menthol 5% (4) 6.5W, Fresh Mint 5% (4) 6.5W, Fresh Mint 5% (4) 4.5W, Fresh Mint 5% (3) 6.5W
- 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.
Golden Tobacco Chill 5% (4) 6.5WOther
Golden Tobacco Chill 5% (4) 6.5W
Glacier Menthol 5% (4) 6.5WOther
Glacier Menthol 5% (4) 6.5W
Fresh Mint 5% (4) 6.5WOther
Fresh Mint 5% (4) 6.5W
Fresh Mint 5% (4) 4.5WOther
Fresh Mint 5% (4) 4.5W
Fresh Mint 5% (3) 6.5WOther
Fresh Mint 5% (3) 6.5W
Fresh Mint 5% (3) 5.5WOther
Fresh Mint 5% (3) 5.5W
Fresh Mint 5% (2) 6.5WOther
Fresh Mint 5% (2) 6.5W
Usual Brand CigaretteOther
Usual Brand Cigarette
| Study group | Role | What they receive |
|---|---|---|
| Product usage order BCNDHEGF | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order CDBENFHG | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order DECFBGNH | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order EFDGCHBN | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order FGEHDNCB | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order GHFNEBDC | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order HNGBFCED | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand Cigarette |
| Product usage order NBHCGDFE | Experimental | Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. Receives: Other: Golden Tobacco Chill 5% (4) 6.5W; Other: Glacier Menthol 5% (4) 6.5W; Other: Fresh Mint 5% (4) 6.5W; Other: Fresh Mint 5% (4) 4.5W; Other: Fresh Mint 5% (3) 6.5W; Other: Fresh Mint 5% (3) 5.5W; Other: Fresh Mint 5% (2) 6.5W; Other: Usual Brand 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 posted31 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 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
- 50 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
- NCT07739797
- Sponsor's protocol ID
- IHI263101
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 8-way Crossover Study to Assess Elements of Abuse Liability Electronic Nicotine Delivery System Products in Adult Smokers
- ClinicalTrials.gov ID
- NCT07739797
- Acronym / sponsor ID
- IHI263101
- Conditions
- Smoking Behaviors, Smoking ( Cigarette), Tobacco Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RAI Services CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 Jul 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, 8-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]) during and following ad libitum use of electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Detailed description
Adult smokers of filtered menthol and/or non-menthol cigarettes and smokers who also use ENDS will be recruited into this study to evaluate elements of ENDS IP AL, in comparison to participant's usual brand (UB) cigarette.
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 10-day, 9-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 each of three ENDS IP (Product C [Glacier Menthol 5%, device, 6.5W], Product F [Fresh Mint 5%, device, 6.5W], and Product H [Fresh Mint 5%, device, 6.5W]) at least once. Use of each ENDS IP 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 IP assigned for use in the subsequent day's test session (excluding their UB cigarette) at least four times. For each ENDS IP, each 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 9, each participant will participate in eight consecutive daily test sessions, evaluating one IP per session. Over the course of the study, each participant will evaluate a total of eight IPs: seven ENDS IPs 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 IP use. Table 1-1 and Table 1-2 outline the schedule of study procedures, and the timing and sequence of activities involving behavioral questionnaires, PK blood sampling and physiological measurements, respectively.
The active period of each test session will start with the assigned IP use initiation and last approximately 4 hours during and following product use. During each test session, participants will be allowed approximately 5 minutes of smoking one UB cigarette and approximately 5 minutes of ENDS IP use based on the product use sequence to which participants will be randomized.
Participants' use of the ENDS IP 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.
ENDS IP e-liquid cartridges will be weighed within 4 hours before and after the test session on Days 2 - 9.
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
- 8
| Arm | Type | Receives |
|---|---|---|
| Product usage order BCNDHEGF | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order CDBENFHG | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order DECFBGNH | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order EFDGCHBN | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order FGEHDNCB | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order GHFNEBDC | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order HNGBFCED | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session. |
| Product usage order NBHCGDFE | Experimental | Other: Golden Tobacco Chill 5% (4) 6.5W, Other: Glacier Menthol 5% (4) 6.5W, Other: Fresh Mint 5% (4) 6.5W, Other: Fresh Mint 5% (4) 4.5W, Other: Fresh Mint 5% (3) 6.5W, Other: Fresh Mint 5% (3) 5.5W, Other: Fresh Mint 5% (2) 6.5W, Other: Usual Brand CigaretteSubjects will use each of the 8 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 (20 listed)
- Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.
- Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
- Positive urine cotinine test at Screening.
- Smokes combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.
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 |
|---|---|---|
| Golden Tobacco Chill 5% (4) 6.5WGolden Tobacco Chill 5% (4) 6.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Glacier Menthol 5% (4) 6.5WGlacier Menthol 5% (4) 6.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Fresh Mint 5% (4) 6.5WFresh Mint 5% (4) 6.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Fresh Mint 5% (4) 4.5WFresh Mint 5% (4) 4.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Fresh Mint 5% (3) 6.5WFresh Mint 5% (3) 6.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Fresh Mint 5% (3) 5.5WFresh Mint 5% (3) 5.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Fresh Mint 5% (2) 6.5WFresh Mint 5% (2) 6.5W | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
| Usual Brand CigaretteUsual Brand Cigarette | Other | Product usage order BCNDHEGF, Product usage order CDBENFHG, Product usage order DECFBGNH, Product usage order EFDGCHBN, Product usage order FGEHDNCB, Product usage order GHFNEBDC, Product usage order HNGBFCED, Product usage order NBHCGDFE |
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 31 Jul 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 Golden Tobacco Chill 5% (4) 6.5W, Glacier Menthol 5% (4) 6.5W and Fresh Mint 5% (4) 6.5W 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 20 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 31 Jul 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 31 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.