What is the purpose of the study?

Smoking is one of the biggest causes of preventable diseases worldwide. Therefore, finding ways to support people who want to stop smoking is an important area of research.

There are currently many different treatments offered to help individuals stop smoking. Current treatment in the UK involves receiving advice from your GP and receiving informational leaflets about the dangers of smoking. You may also be offered nicotine replacement therapy (NRT) including nicotine patches, inhalers, spray or gum, or other types of medication that help control cravings and support your quit attempts.

Another type of treatment not routinely offered in the UK is called cognitive behavioural therapy (CBT). This is a type of psychological therapy which helps you manage your problems by changing the way you think about them, and therefore how you behave in response to them. Research has shown this is highly effective in smoking cessation.

The aim of this study is to test the effectiveness of these different existing methods in helping individuals who want to quit smoking, while they also use NRT if they choose to do so.

What will happen in the study?

If you are happy to take part in the study, you will be asked to complete a questionnaire asking questions about you, your smoking habits, as well as about your general health and wellbeing. Following that, you will be invited to a face-to-face session in a central London (UK) location. Here you will be able to ask any questions you have, provide your informed consent to participate in the study, and you will be entered into the study. You will randomly receive one of two possible behavioral interventions. In addition to this intervention, a trained practitioner will offer you nicotine replacement therapy (NRT) to support your quit attempt if you are interested.

Following completion of the above tasks during the baseline interview, you will be invited to complete surveys regarding your smoking behavior 4, 26, and 52 weeks after your quit date.

The purpose of these surveys is to help us determine if your quit attempt was successful, as well as to evaluate your attitudes and perceptions around smoking and general health and wellbeing following completion of the intervention.

You will be compensated for participation at the following schedule: £10 for the initial visit, £20 for week 4, £10 for week 26, and a final £20 for week 52.

What are the possible benefits of taking part?

The treatments offered may increase your chances of successfully giving up smoking. However, this cannot be guaranteed. The information we get from this study will help us determine how different existing interventions compare with one another in improving success of a quit attempt.

How will we use your data?

Digital Therapeutics, Inc is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. We will keep identifiable information about you for 1 year after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

GP practices will collect information from you for this research study in accordance with our instructions. They will use your name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Digital Therapeutics, Inc and regulatory organisations may look at your medical and research records to check the accuracy of the research study. GP practices will pass these details to the research team along with the information collected from you. The only people in Digital Therapeutics, Inc who will have access to information that identifies you will be people who need to contact you to regarding your participation in the study or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details.

The research will keep identifiable information about you from this study for 1 year after the study has finished. You can find out more about how we use your information at www.thesmokingsurvey.com or by contacting the research team.

What will happen to the research?

The findings of the research will be published in a scientific journal. No identifiable information will ever be used in any report or publication. If you would like a copy of the results, these will be made available to you.

Who is organizing and funding the research?

The sponsors of this study is Digital Therapeutics, Inc.

Who has reviewed this study?

This study has received a favourable ethical opinion from Health and Social Care Research Ethics Committee A (HSC REC A).

Contacts for further information

For further information, please contact the research team.

Dr Sarim Siddiqui
Chief Medical Officer
Digital Therapeutics, Inc
The Record Hall, 16-16A Baldwin’s Gardens
London, EC1N 7RJ
[email protected]