An open-label, randomised, single-dose, three-way cross-over trial to assess the pharmacokinetics of NIC24-01 and NIC24-02 oromucosal pouches (a nicotine replacement therapy) in comparison to Nicorette® 4 mg gum in healthy adult smokers under fasted conditions.
This research study is about finding new and effective ways to help people quit smoking. We are testing new nicotine pouches, called NIC24-01 and NIC24-02, which are a type of nicotine replacement therapy. These pouches are designed to help reduce cravings when you’re trying to stop smoking. We want to see how these new pouches work in the body compared to a widely used product, Nicorette 4mg gum. We'll be looking at how quickly and how much nicotine gets into the bloodstream. This is a small, early-stage study involving healthy adult smokers. The goal is to understand if these new pouches could be a good option for people trying to stop smoking in the future.
At a glance
What is this study about?
This study is all about helping people stop smoking. We know it's a big challenge for many, and nicotine replacement therapies like patches, gum, or lozenges can really help reduce cravings and withdrawal symptoms. In this study, we're exploring two new nicotine pouches, NIC24-01 and NIC24-02. These pouches are designed to deliver nicotine into your body through your mouth, similar to how some existing products work.
The main goal is to understand how these new pouches work inside your body. We want to see how quickly the nicotine gets into your bloodstream and how long it stays there, compared to a well-known product, Nicorette 4mg gum. Think of it like a test drive – we're trying out these new options to see how they perform.
By carefully comparing these new pouches with an established product, we hope to learn if they could be effective and safe options for people trying to quit smoking in the future. This kind of early research is really important for developing new and better tools to support people on their journey to becoming smoke-free.
Key takeaways
- The study is testing new nicotine pouches to help people quit smoking.
- It compares new pouches to existing Nicorette gum.
- It involves healthy adult smokers aged 18 and over.
- Participation involves multiple clinic visits and blood tests.
- The aim is to understand how nicotine is absorbed into the body.
Who may be eligible?
To be able to take part in this study, you need to be an adult smoker, aged 18 or older. Both men and women can participate. The study is particularly looking for people who are generally healthy, as this helps researchers understand the new products clearly without other health conditions affecting the results.
There might be other specific health requirements or conditions that would mean you couldn't join. For example, if you have certain medical conditions or take specific medications, you might not be eligible. This is to make sure the study is safe for everyone involved and that the results are reliable.
It's important to remember that the research team will check all these details carefully to make sure the study is right for you and you are right for the study.
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 18 years old or older?
- Do you currently smoke regularly?
- Are you generally healthy?
- Are you willing to visit a clinic several times?
- Are you able to follow specific instructions, like not eating before visits?
What does participation involve?
If you decide to take part, you'll visit the study clinic multiple times. On each visit, you'll be given either one of the new nicotine pouches or Nicorette gum to use. You'll need to use these when your stomach is empty (this is called 'fasted conditions'). Over several hours after you use the product, the study team will take small blood samples to measure how much nicotine is in your body and how it's being processed.
Because this is a 'cross-over' study, you'll try all three products (NIC24-01, NIC24-02, and Nicorette gum) at different times, with a break in between each test to make sure one product doesn't affect the next. The total time you'll spend actively taking part in the study, including all your visits and follow-ups, will be spread out over a few weeks.
Potential risks and benefits
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Common questions
What does 'nicotine dependence' mean?
It means you regularly use tobacco products and have difficulty stopping, often experiencing cravings or withdrawal symptoms if you try to quit.
What is an 'oromucosal pouch'?
It's a small pouch that you place in your mouth against your gum, and it slowly releases nicotine which is absorbed through the lining of your mouth.
What does 'fasted conditions' mean?
It means you haven't eaten anything for a certain number of hours before taking the study product this helps ensure the most consistent and accurate results for how the body takes in the nicotine.
Will I have to stop smoking entirely for this study?
The study looks at healthy adult smokers. The research team will explain the specific requirements regarding your smoking habits during the study.
Will I be paid to take part?
It's common for studies like this to provide some compensation for your time and travel, but specific details would be discussed by the research team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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