A study to assess nicotine uptake to the bloodstream after use of six different oral nicotine products in adult smokers
| ISRCTN | ISRCTN14991807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14991807 |
| Integrated Research Application System (IRAS) | 362705 |
| Sponsors | British American Tobacco (United Kingdom), Nicoventures Trading Limited |
| Funders | British American Tobacco, Nicoventures Trading Limited |
- Submission date
- 25/11/2025
- Registration date
- 26/11/2025
- Last edited
- 25/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
The main purpose of this clinical study is to learn how much nicotine is in the blood of adult smokers after using each of the six oral nicotine products measured by blood sampling. The other purpose of this clinical study is to learn, by collecting questionnaires, about product liking, flavour, positive/negative effects the study products have on you and how the study products affect your urge to smoke and mood.
Who can participate?
Smokers aged 19-55 years
What does the study involve?
1. Staying at the research site for 8 days.
2. Undergo a training session for how to correctly use the different nicotine products.
3. Following a successful training session, participants will be randomly assigned an order to use the study products.
On each product test session (6 in total), an oral nicotine product will be used in the morning following going without nicotine or tobacco products for 24 hours and without food for 8 hours. During the test session, blood samples will be collected regularly and questionnaires completed.
What are the possible benefits and risks of participating?
There are no positive health benefits from participating. This study is for research purposes only.
Where is the study run from?
Celerion (UK)
When is the study starting and how long is it expected to run for?
December 2025 to January 2026
Who is funding the study?
1. British American Tobacco (Investments) Limited (UK)
2. Nicoventures Trading Limited (UK)
Who is the main contact?
Olivia Tookey, olivia_tookey@bat.com
Contact information
Ms Olivia Tookey
Scientific, Public
Scientific, Public
R&D Centre, Regents Park Road
Southampton
SO15 8TL
United Kingdom
| Phone | +44 (0)7591836390 |
|---|---|
| olivia_tookey@bat.com |
Mr Devinda Weeraratne
Principal investigator
Principal investigator
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
| Phone | +44 (0)2890554059 |
|---|---|
| devinda.weeraratne@celerion.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Crossover | |
| Purpose | To assess the nicotine uptake in the blood of six oral nicotine products | |
| Scientific title | Single exposure, randomised, crossover study to assess the pharmacokinetics of six oral nicotine products in adult smokers under fasting conditions | |
| Study objectives | This single exposure study is designed in accordance with regulatory guidelines, with the aim of characterising the bioavailability of nicotine in the six products in adult cigarette smokers. As this is a comparative bioavailability study where each participant will receive each study product in a crossover fashion, a control group is not included. The primary objective of this study is to compare the nicotine PK parameters between the Test products and each of the three Reference products after a single administration under fasting conditions. The secondary objectives are to compare the nicotine pharmacokinetic parameters between the Test product(s) and the appropriate Reference products, to assess multiple subjective measures via questionnaires, and to evaluate the safety and tolerability of a single use of the three Test and the three Reference products. | |
| Ethics approval(s) |
Approved 29/10/2025, Wales Research Ethics Committee 2 (Health and Care Research Wales, Floor 4, Crown Building, Cathays Park, Cardiff, CF10 3NQ, United Kingdom; +44 (0)2922941119; Wales.REC2@wales.nhs.uk), ref: 25/WA/0296 | |
| Health condition(s) or problem(s) studied | Nicotine uptake | |
| Intervention | Participants: 1. Stay at the research site for 8 days. 2. Undergo a training session for how to correctly use the different nicotine products. 3. Following a successful training session, participants will be randomly assigned an order to use the study products. On each product test session (six in total), an oral nicotine product will be used in the morning following going without nicotine or tobacco products for 24 hours and without food for 8 hours. During the test session, blood samples will be collected regularly and questionnaires completed. 2 mg Nicotine Pouch (Test) 2 mg Mini Nicotine Pouch (Test) 4 mg Mini Nicotine Pouch (Test) 2 mg Nicotine Lozenge (Reference) 4 mg Nicotine Pouch (Reference) 2 mg Nicotine Gum (Reference) The randomisation approach for this study is the William Design/Latin Square. | |
| Intervention type | Other | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 13/01/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 42 |
| Key inclusion criteria | 1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Adult male or female 4. If female, and is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first study product administration through to at least 30 days after the last use of study product. 5. Aged at least 19 years but not older than 55 years 6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively 7. Minimal body weight of 50 kg 8. Primary tobacco product used in the last 6 months is combustible cigarettes or roll your own cigarettes 9. A smoker of 10 cigarettes or more per day who has smoked for at least 6 months prior to the first study product administration, except for brief periods of abstinence due to illness, quit attempt (prior to 28 days of Screening), or clinical study participation (prior to 28 days of Screening) will be allowed at the discretion of an investigator 10. 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”. 11. Stated willingness to abstain from nicotine and tobacco products (except for the study products provided) from 24 hours prior to the first study product administration until the end of the study 12. Positive urine cotinine test (≥200 ng/mL) at Screening and prior to the first study product administration 13. Expired breath carbon monoxide (eCO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day -2) 14. Successful completion of the training session for study product use prior to the first study product administration (participant is able to follow the instructions and does not experience significant AEs during the training session) 15. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator 16. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including oral mucosa examination and vital signs) and/or ECG, as determined by an investigator |
| Key exclusion criteria | 1. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study 2. Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study product administration 3. Presence of braces, partials, dentures or any dental work that could, in the opinion of an investigator, affect the conduct of the study (including missing molars) 4. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction 5. Use of tobacco and/or nicotine containing products, other than combustible cigarettes, (e.g., e-cigarette/vapes pods, tanks, nicotine-containing pouches or disposables, or heated tobacco products) more than one day per week for the past 6 months prior to Screening or at any time in the last 28 days 6. History of significant hypersensitivity to any excipients of the formulations as well as severe hypersensitivity reactions (like angioedema) to any drugs 7. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability 8. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 9. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment 10. Maintenance therapy with any drug (with the exception of hormonal contraceptives or hormone replacement therapy) 11. Significant history of drug dependency or alcohol abuse (> 14 units of alcohol per week, intake of excessive alcohol, acute or chronic) 12. Any clinically significant illness in the 28 days prior to the first study product administration 13. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study product administration, that in the opinion of an investigator would put into question the status of the participant as healthy 14. Use of all formats of pseudoephedrine in the 7 days prior to the first study product administration 15. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or Lobelia extract in the 28 days prior to the first study product administration 16. Any history of tuberculosis 17. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first product administration. 18. Positive Screening results for HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 19. Inclusion in a previous group for this clinical study 20. Intake of an Investigational Product in any other clinical trial in the 28 days prior to the first study product administration 21. Haemoglobin level is <12.5 g/dL for females or <13.5 g/dL for males at Screening 22. Donation of 500 mL or more of whole blood or lost blood or blood products in the 56 days prior to the first study product administration 23. Plasma donation within (≤) 7 days prior to signing the informed consent or between Screening and check-in Day -2 24. A postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study 25. Previously attempted to quit using tobacco- or nicotine-containing products in the 28 days prior to the first study product administration 26. Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job |
| Date of first enrolment | 06/12/2025 |
| Date of final enrolment | 06/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Celerion
22-24 Lisburn Road
Belfast
BT9 6AD
Northern Ireland
Belfast
BT9 6AD
Northern Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
25/11/2025: Study's existence confirmed by the Wales Research Ethics Committee 2.
