An interventional study of Golden Tobacco Chill 5% (4) 6.5W and Glacier Menthol 5% (4) 6.5W 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 2026-07-31.
Sponsored by RAI Services Company (part of British American Tobacco) · Not applicable, Interventional, and Other
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.
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.
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 50 is below 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.
Participants must meet one (a or b) of the following tobacco use conditions:
a. 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.
Females must be willing to use a form of 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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
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
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
Fresh Mint 5% (3) 5.5W
Fresh Mint 5% (2) 6.5W
Usual Brand 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
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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