A study to assess nicotine uptake to the bloodstream after use of six different oral nicotine products in adult smokers
This research study aims to understand how much nicotine enters the bloodstream of adult smokers when they use six different oral nicotine products. The study will also gather information about how participants like the products, their flavour, and any positive or negative effects they experience. We'll also see how these products influence their desire to smoke and their mood. Participants will stay at a research centre for eight days. During this time, they will learn how to use the products correctly and then try each product, one at a time. Blood samples will be taken regularly, and questionnaires will be completed to collect all the necessary information. This study is funded by British American Tobacco and Nicoventures Trading Limited.
At a glance
What is this study about?
This research study is looking for adult smokers aged 19 to 55 to help us understand more about different oral nicotine products. The main goal is to find out exactly how much nicotine from six different oral products gets into a smoker's blood. This is important scientific information that helps us learn more about these products.
But it's not just about nicotine levels. We also want to hear from you. The study will ask about your experience with each product, including what you think of the flavour, any good or bad feelings they cause, and whether they affect your mood or your urge to smoke. Your feedback is really valuable as it helps us understand the real-world effects of these products.
This study involves staying at a research centre for eight days. You'll be given clear instructions on how to use each product, and then you'll try them out. It’s important to remember that this study is purely for research purposes. It won't offer any health benefits, but your participation will contribute to scientific knowledge.
Key takeaways
- Study explores nicotine levels from oral products in smokers.
- Aims to understand user experience and mood effects.
- Involves an 8-day stay at a research facility.
- Participants must be adult smokers aged 19-55.
- No direct health benefits from participation, research-focused.
- Funded by tobacco-related companies.
Who may be eligible?
To join this study, you need to be a smoker between 19 and 55 years old and generally in good health. You must be willing to stay at the research site for 8 days and follow all the study rules.
You should be someone who smokes at least 10 cigarettes a day and has been smoking for at least six months. We'll check your nicotine levels to make sure you're a regular smoker. You'll also need to be able to read and understand English to complete the consent forms and questionnaires.
There are also some specific health checks, like your Body Mass Index (BMI) needing to be within a certain range (18.5 to 30), and women of childbearing potential will need to agree to use effective contraception throughout the study and for a short time afterwards.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 19 and 55 years old?
- Do you smoke at least 10 cigarettes a day and have you smoked for at least 6 months?
- Are you able to stay at a research site for 8 days?
- Are you able to understand and complete questionnaires in English?
- Is your Body Mass Index (BMI) between 18.5 and 30?
- Are you willing to avoid nicotine and food for set periods before tests?
What does participation involve?
If you decide to take part, you will need to stay at a research site for a total of 8 days. Before you start, you'll have a training session to make sure you know how to use the different nicotine products correctly. Then, the study team will decide the order in which you’ll try the six products.
On each of the six test days, you'll use one of the oral nicotine products in the morning. However, before each test day, you'll need to avoid all nicotine and tobacco products for 24 hours and avoid food for 8 hours. During these test sessions, the study team will take regular blood samples to measure nicotine levels. You will also be asked to complete questionnaires about your experience, feelings, and urges to smoke. After all treatments are completed, there is no further follow-up required.
Potential risks and benefits
Locations (1)
- CelerionApproximateBelfast, Northern Ireland
Common questions
What is the main goal of this study?
The main goal is to measure how much nicotine from different oral products gets into the blood of adult smokers and to understand their experiences with these products.
How long do I need to stay at the research site?
You will need to stay at the research site for 8 days in total.
Will I get any money for participating?
The study information provided does not mention direct payment for participation, but you should discuss this with the study team if you are interested.
What kind of questionnaires will I need to fill out?
The questionnaires will ask about your liking of the products, their flavour, any positive or negative effects they have, and how they affect your urge to smoke and your mood.
Who is paying for this research?
This study is funded by British American Tobacco (Investments) Limited and Nicoventures Trading Limited.
How to find out more
Olivia Tookey
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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