Active not recruitingNAINTERVENTIONAL

Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers

This research is looking into how nicotine from two different versions of a new type of e-cigarette, called VM 1.0 (VM16 and VM32), works in the body compared to regular cigarettes. The study will involve adult smokers and aims to understand how quickly nicotine gets into their system, how long it stays there, and what effects it has. Participants won't know which e-cigarette version they are using at certain times. It’s a carefully planned study with different phases to get clear results. The goal is to get a better understanding of how these new e-cigarettes deliver nicotine compared to traditional smoking.

At a glance

Status

Active not recruiting

Phase

Sponsor

Philip Morris Products S.A.

Enrolment target

Start

17 Jul 2025

Estimated completion

06 Oct 2025

Nicotine

What is this study about?

This study is about understanding how nicotine from a new type of e-cigarette, called VM 1.0, behaves in the body compared to nicotine from regular cigarettes. Researchers are looking at two different versions of VM 1.0, known as VM16 and VM32. They want to see how quickly the nicotine from these products gets into a smoker's system and how long it stays there. They'll also be checking the effects these products have on the body.

The study involves adult smokers and is designed to compare these products fairly. Some parts of the study will be 'blinded', meaning participants won't know if they are using VM16 or VM32 at that time. This helps to make sure the results are as unbiased as possible. By doing this, the researchers can get a clear picture of how these new e-cigarettes deliver nicotine compared to traditional smoking.

Understanding these differences is important for developing and evaluating new nicotine products. The information gathered can help scientists, and potentially health organisations, to understand the different ways people take in nicotine from various products.

Key takeaways

Compares nicotine from new e-cigarettes (VM 1.0) to regular cigarettes.
For adult smokers aged 21-65 who smoke at least 10 cigarettes daily.
Involves using different products and periods of no nicotine.
Requires regular clinic visits for health checks and tests.
Your health and well-being are a top priority throughout the study.

Who may be eligible?

To join this study, you need to be an adult smoker between 21 and 65 years old. You should have been smoking cigarettes for at least a year and usually smoke at least 10 cigarettes a day. We'll also check your nicotine levels to make sure you're a regular smoker, and you'll need to be in good overall health with a healthy body weight.

There are also some reasons why you might not be able to take part. For example, if you have certain health conditions that need regular medication, or if you have a fever, or issues with blood tests. Also, if a doctor decides for any reason that it's not safe or suitable for you to join, you wouldn't be able to participate. This includes if you have conditions that need medical attention or surgery during the study period, or difficulties with having blood taken.

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 21 and 65 years old?
Have you smoked cigarettes for at least the last 12 months?
Do you currently smoke at least 10 cigarettes a day?
Are you generally healthy and at a healthy weight?
Are you able to attend all study visits and follow specific instructions?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be giving your permission by signing a consent form. You'll switch between using regular cigarettes and the two different versions of the VM 1.0 e-cigarette. The study is split into three different periods, and you'll follow a specific sequence of products. During certain times, you'll need to completely avoid all nicotine and tobacco products. You’ll also need to stick to a special diet. It's important that you're available for the entire study period and are willing to follow all the instructions precisely. This will likely involve regular visits to the clinic for assessments like blood tests, physical exams, and checking your vital signs.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might gain a better understanding of your own nicotine use and contribute valuable information to medical science. However, there's always a chance of discomfort from medical procedures like blood tests. You might also experience side effects from the products, though the study is designed to be as safe as possible. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Celerion
Verified postcode
Belfast, United Kingdom

Common questions

What is VM 1.0?

VM 1.0 is a new type of e-cigarette, and this study looks at two variations of it (VM16 and VM32).

Will I know if I'm using the e-cigarette or a regular cigarette?

You will know when you are using regular cigarettes, but during some parts of the study, you won't know which version of VM 1.0 you are using.

Do I have to quit smoking for this study?

You will need to completely stop using all nicotine and tobacco products for certain periods during the study, as instructed by the research team.

What kind of tests will I have?

You can expect tests like blood samples, checks of your physical health, and measurements of things like your heart rate and breathing.

How long will the study last?

You should be available for the entire study period, which will be explained in detail before you agree to take part.