Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Parallel group, Double-blind, Placebo-controlled, Randomized, Efficacy and Safety Study of Nicotine Freshmint Mouthspray in E-cigarette Users Willing to Quit

This study is for people who use e-cigarettes and want to quit. Researchers are testing a nicotine mouth spray, like the Nicorette Mint Spray, to see if it helps them stop vaping. Participants will be given either the real nicotine spray or a dummy spray that looks and tastes the same but has no nicotine. The study will check if people can stay off e-cigarettes for a whole year. They will also look at how often people feel like vaping or smoking, and track any side effects to make sure the spray is safe. The aim is to find effective ways to help people stop using e-cigarettes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

McNeil AB

Enrolment target

200

Start

09 Jan 2024

Vaping cessation in e-cigarette users

What is this study about?

This study is looking into a new way to help people who use e-cigarettes, also known as vaping, to stop. It's an important step in understanding how different methods can support people on their quitting journey. The main goal is to see if a specific nicotine mouth spray can help people successfully stop using e-cigarettes and stay off them for a long time.

To do this, the study will compare the nicotine mouth spray to a "dummy" spray, called a placebo. The dummy spray looks and feels exactly like the real one but doesn't contain any nicotine. This helps the researchers truly understand if the effects they see are from the nicotine in the spray or from other factors. Neither the participants nor the doctors will know who is getting the real spray and who is getting the dummy spray, which helps make the results as fair and accurate as possible.

Throughout the study, which lasts for about a year, researchers will carefully check if participants are still using e-cigarettes. They'll also monitor any urges to vape or smoke, and keep an eye on how participants are feeling overall to make sure the treatment is safe. By the end, they hope to have a clear idea of whether this nicotine mouth spray is an effective and safe tool to help people quit vaping.

Key takeaways

This study is testing a nicotine mouth spray to help people stop vaping.
Participants will receive either the real nicotine spray or a dummy spray.
The study lasts for about a year with regular check-ups.
It aims to find out how well the spray works and if it's safe to use.
Participation involves clinic visits and recording daily information.
You can leave the study at any time if you change your mind.

Who may be eligible?

This study is specifically designed for adults aged 18 or older who currently use e-cigarettes and want to stop. Both men and women are welcome to take part.

You would need to be committed to trying to quit vaping for the duration of the study. There will also be some specific health checks to make sure the study is a good fit for you and that it's safe for you to participate.

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 use e-cigarettes?
Do you want to stop vaping?
Are you able to attend appointments for about a year?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the active nicotine mouth spray or a dummy spray. You won't know which one you're getting, and neither will your study doctor. You'll use this spray as directed and your progress will be checked regularly.

Over the course of about a year, you'll have several visits to the clinic. During these visits, researchers will ask you about your e-cigarette use, your urges to vape or smoke, and how you are feeling generally. They will also take some simple tests, like a breath test, to check if you're still using e-cigarettes or traditional cigarettes. We will also ask you to record daily information about your vaping and urges in an electronic diary for the first couple of weeks.

The total duration of your active involvement in the study will be approximately 52 weeks (about one year), with follow-up appointments at various points to check on your progress.

Potential risks and benefits

Taking part in this study could potentially help you quit vaping through a structured programme and a nicotine spray. You will also be closely monitored by healthcare professionals. While the nicotine mouth spray is generally well-tolerated, like all medicines, it can have side effects, such as mild irritation in the mouth or throat. The dummy spray has very few risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'dummy spray'?

A dummy spray (placebo) looks and feels exactly like the real nicotine spray but doesn't contain any active medicine. It helps researchers know if the effects are from the actual medicine or something else.

Will I know if I'm getting the real spray or the dummy spray?

No, neither you nor your study doctor will know whether you are receiving the real nicotine spray or the dummy spray. This helps ensure the study results are fair.

How long will I be in the study?

You'll be in the study for about one year, with regular visits to the clinic during that time.

What happens if I want to stop taking part?

You are free to leave the study at any time, for any reason, without your medical care being affected.

What will the study check for?

The study will check if you can successfully stop using e-cigarettes, how often you feel like vaping or smoking, and any side effects you might experience from the spray.