An open-label, randomized, single-dose, two-way cross-over study to assess the tolerability and pharmacokinetics of NRT001 nicotine buccal film compared with an oromucosal nicotine spray in adult occasional nicotine users
Nicotine replacement therapy helps people manage cravings when they are cutting down or quitting smoking. This clinical trial is testing a new product called NRT001. It is a thin film placed inside the cheek (buccal film) that dissolves and releases nicotine. The main aim of this study is to compare the NRT001 film with an existing nicotine mouth spray. Researchers want to find out how much nicotine enters the bloodstream, how quickly it gets there, and whether it causes any uncomfortable mouth or stomach side effects. The study involves healthy adults aged 18 and older who use nicotine occasionally. Because it is a 'cross-over' trial, participants will test both the film and the spray on separate occasions, allowing researchers to directly compare how the body handles each product.
At a glance
What is this study about?
When people try to quit smoking or cut down on tobacco, nicotine cravings can be one of the hardest hurdles to overcome. Nicotine replacement therapy (NRT) provides a cleaner way to receive nicotine without the harmful chemicals and tar found in tobacco smoke. Today, people use patches, gums, inhalers, and mouth sprays. Researchers are constantly looking for new, more comfortable, and faster-acting ways to deliver nicotine replacement.
This study tests a new option called NRT001. It is a small, dissolvable film that is placed directly onto the inside lining of the cheek. As it melts away, nicotine is absorbed straight through the lining of the mouth into the bloodstream. This Phase 1 trial aims to understand how smoothly the body takes in nicotine from this film compared to a standard nicotine mouth spray that is already available.
During the trial, scientists will track how quickly nicotine enters the blood and how long it stays there. They will also check how comfortable the film is to use and whether it causes any irritation in the mouth or typical nicotine side effects like mild nausea or hiccups. This study is an important first step in finding out whether a dissolvable cheek film could become a useful, convenient choice for people seeking help with nicotine cravings in the future.
Key takeaways
- Tests a new dissolvable nicotine cheek film called NRT001.
- Compares the new film directly against an existing nicotine mouth spray.
- Open to healthy adults aged 18 and older who use nicotine occasionally.
- A cross-over trial where every participant tries both products on separate visits.
- Helps scientists gather safety and absorption data to design better quit-smoking aids.
Who may be eligible?
This study is looking for adults aged 18 and over who use nicotine from time to time (occasional nicotine users). Because this is an early safety study, researchers usually look for people who are in good general health.
You may not be able to take part if you have certain health conditions, such as severe heart problems, high blood pressure that is not controlled, or significant mouth sores or gum disease that could affect how the film dissolves. You may also be excluded if you take regular medications that could interact with nicotine or if you are pregnant or breastfeeding.
A full health check and medical history review will be completed by the study team before anyone is enrolled to ensure it is completely safe for them to take part.
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 aged 18 or older?
- Do you use nicotine products occasionally?
- Are you in good general health?
- Are you free from serious mouth sores or oral health conditions?
- Are you able to attend clinic visits and give blood samples?
What does participation involve?
Taking part in this study involves visiting a specialist clinical research unit. Because this is a 'two-way cross-over' study, each volunteer will try both products: the new nicotine cheek film once, and the nicotine mouth spray once, on two separate visits. There will be a short break between visits so the nicotine completely clears from your body.
During each visit, a single dose will be given. The medical team will take regular blood samples over several hours to measure how much nicotine enters your bloodstream. They will also monitor your heart rate, check your blood pressure, and inspect the inside of your mouth to see how your cheek reacts. The total time in the study usually lasts a few weeks, from the first screening visit to a final follow-up check.
Potential risks and benefits
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Common questions
What is a buccal film?
A buccal film is a very thin, flexible strip that you place against the inside of your cheek. It slowly melts away on its own, allowing the medication to be absorbed directly through the lining of your mouth.
What does a 'cross-over' study mean?
A cross-over study means you will get to try both treatments at different times. You will test the new cheek film on one visit and the nicotine mouth spray on another visit, allowing researchers to compare how your body reacts to each one.
Will taking part help me stop smoking permanently?
No. This study is an early-stage research test to check how the body absorbs nicotine from a single dose. It is not a complete quit-smoking programme.
Will I be paid for my time?
Phase 1 trials often provide payment to compensate volunteers for their time, travel, and inconvenience. The study doctor can give you full details about any payments.
Can I leave the study if I change my mind?
Yes. Taking part is entirely your choice. You can withdraw at any time, for any reason, and it will not affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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