Project details

Summary

What is the study about?

The main purpose of this study is to assess whether an investigational product, called Nicotine Freshmint Mouthspray, could help people to quit vaping. Smoking tobacco, such as cigarettes, can lead to exposure to nicotine and other harmful elements, such as carbon monoxide (CO) and ammonia.

E-cigarettes are devices that allow users to inhale nicotine as vapours. Some people may use e-cigarettes to help quit smoking. However, using e-cigarettes also have known health risks, such as worsening of asthma, inflammation of the lungs, addiction and abuse, and chances of smoking cigarettes in future. There is a need for safe and proven ways of helping people to quit e-cigarettes. The use of e-cigarettes is called ‘vaping’.

The study will also look at whether the investigational product is safe and has any effect on the urges to vape or the withdrawal symptoms of vaping. Withdrawal symptoms of vaping include irritability or aggression (feeling angry), feeling impatient or frustrated, anxiety, restlessness, low concentration, increased appetite, weight gain, urges to vape, or sleep disturbances.

With the use of this investigational product, we hope to provide an effective method for stopping vaping for people who are motivated to quit.

All new medications, including nicotine replacement therapies (NRT), must undergo thorough testing in clinical research studies before they can be prescribed by doctors or be available over the counter.

Without clinical research studies, no new medications would be developed, and few medical advances would be made. It is important that the participants in clinical research studies are diverse and that all kinds of people are represented. 

What are you trying to find out?

The purpose of this clinical research study is to assess whether a mouth spray (Nicotine Freshmint Mouthspray) can help e-cigarette users to quit vaping. The mouth spray is a marketed medicine that can help cigarette users (smokers) stop smoking. It is also designed to help stop vaping.

With the use of this investigational product, we hope to provide an effective method for stopping vaping for people who are motivated to quit. This is a Phase 3 study, which means that the investigational product has been studied previously in other people. Phase 3 studies are completed to expand on the information already obtained from previous studies. The aim of Phase 3 studies is to provide a thorough understanding of whether or not the investigational product works, the benefits from it, and its safety.

What does taking part involve?

If you choose to take part, you will be asked to take the study mouth spray for at least 12 weeks. You will need to complete an electronic diary for 4 weeks during the study. You will need to stop using e-cigarettes once you start taking the study mouth spray. You will also need to stop using all other tobacco- and nicotine-containing products 7 days before your first study visit (screening visit).

You will be randomly assigned (by chance) to take either the Nicotine Freshmint Mouthspray or a placebo mint mouth spray. You will have a 1-in-2 chance of receiving the Nicotine Freshmint Mouthspray. You and the study doctor will not know which mouth spray you are taking. However, the study doctor can find out in case of an emergency. 

If you agree to participate in this study, you will be asked to read, sign and date the Informed Consent Form at the end of this document. You will be in the study for a little over 1 year (54 weeks). You will have up to 12 visits including 9 study site visits and 3 remote visits through telephone or video calls.

The study is split into 4 parts:

• Screening period (about 2 weeks) and baseline visit
• Study treatment period (about 26 weeks, Weeks 1–26)
• Off study treatment period (26 weeks, Weeks 26–52)
• End-of-study visit (Week 52)

Who is it for?

We are looking for participants who are: 

• are 18 years of age or older and are generally healthy
• have been using electronic cigarettes (e-cigarettes) every day for at least the past 3 months
• have not smoked a conventional (regular) cigarette or used other forms of nicotine (such as cigars, pipes, chewing tobacco, or nicotine pouches) during the past 7 days
• are highly motivated to quit using nicotine in any form

About 800 participants from the United Kingdom, Canada and Germany are expected to take part.

Why is it important? 

The study mouth spray is designed to help you quit vaping. However, this cannot be guaranteed and there may not be any direct benefit for you if you take part in this study. Information from this study may help researchers understand more about how the study mouth spray may help other people quit vaping in the future.

As part of the study, qualified study doctors and nurses will closely monitor your health. Our screening tests might be of benefit if we find an important medical problem, but they could reveal something you would prefer not to know about. Please tell your study doctor if you do not wish to be informed of such information.

How can I find out more?

You can find out more information about taking part in this study by downloading the key documents at the top of this page. You can also visit the CloudFree project website here.

If you are interested in taking part in this study, or have questions for the research team, click the button below to email us:

Email the research team