All studies
Active not recruitingPHASE3INTERVENTIONAL

PeRiopEratiVE SmokiNg CessaTion Trial

The PREVENT study is a clinical trial exploring better ways to help people stop smoking before having surgery. Researchers are comparing two main approaches: a medication called cytisine against a dummy pill (placebo), and supportive video messages versus standard care. The main goal is to see if these methods help people quit smoking for at least six months. They will also check other things like how soon people might slip up, if they have fewer surgery complications, and how long they stay in hospital. This study is for people aged 18 or over who smoke, are about to have surgery, and have a smartphone.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Population Health Research Institute
Enrolment target
1,720
Start
15 Jan 2024
Estimated completion
01 Jan 2027

What is this study about?

The PREVENT study is looking into new ways to help people stop smoking, especially before they have an operation. We know that stopping smoking before surgery can lower the risk of problems and help you recover better. This study is testing two different approaches to see how well they work.

Firstly, it's looking at a tablet called cytisine. This medicine can help reduce cravings for nicotine, making it easier to quit. Some people in the study will get the cytisine tablet, while others will receive a dummy pill (placebo) that looks the same but has no active ingredient. This helps researchers understand if cytisine itself is effective.

Secondly, the study is investigating whether supportive video messages can help motivate people to quit. Some participants will receive these messages, while others will get the usual support available. By comparing these different methods, the researchers hope to find the best ways to help people stop smoking permanently and improve their health outcomes, especially around the time of an operation.

Key takeaways

  • This study helps people stop smoking before surgery.
  • It tests a pill (cytisine) and video support messages.
  • It aims to see if these methods help people quit for 6 months.
  • Stopping smoking before surgery can improve recovery.
  • Participants will have regular check-ups for 6 months.

Who may be eligible?

To join this study, you need to be at least 18 years old and currently smoke cigarettes. You should also be scheduled for surgery within the next 28 days and not currently using any other stop-smoking treatments. You'll need a smartphone with internet access and a data plan, and you must be willing to give your informed consent.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant. You also can't join if you've already had a serious allergic reaction to cytisine or its ingredients, or if you've had a heart attack or stroke recently (within the last two weeks).

Other reasons for not being able to take part include having certain uncontrolled health conditions like severe high blood pressure, severe kidney or liver disease, or some serious mental health conditions. If your surgery means you can't eat or drink for two or more days, or if you've already been part of this PREVENT study before, you also wouldn't be able 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.

  1. Are you 18 years old or older?
  2. Do you currently smoke cigarettes and want to quit?
  3. Are you having surgery within the next 28 days?
  4. Do you have a smartphone with internet access?
  5. Are you NOT currently pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you join the PREVENT study, you would be randomly assigned to one of four groups. This means you might receive the cytisine medicine or a dummy pill, and you might get supportive video messages or the usual care. You'll take the assigned medication (or placebo) and, if in that group, use the video messaging for a period leading up to and after your surgery. You will likely have regular check-ins or assessments at 30 days, 56 days, and then 6 months after you start the study. These check-ins will help researchers understand if you've stopped smoking, how you're feeling, and if you've experienced any surgery-related complications. The total duration of your active participation and follow-up in the study would be for six months.

Potential risks and benefits

Participating in this study might offer you the benefit of trying a new approach to quit smoking, potentially improving your health and surgical recovery. However, there's no guarantee that you will stop smoking or that you will personally benefit. Potential risks include possible side effects from the medication, though these will be carefully monitored. Discuss any concerns with the study team. Remember, you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

  • Hamilton General Hospital
    Verified postcode
    Hamilton, Canada
  • Juravinski Cancer Centre
    Verified postcode
    Hamilton, Canada
  • Kingston Health Science Centre with its research institute Kingston General Health Research Institute
    Verified postcode
    Kingston, Canada
  • Lawson Health Research Institute: London Health Sciences Centre Research Inc. and the Lawson Research Institute
    Verified postcode
    London, Canada

Common questions

What is cytisine?

Cytisine is a medicine that can help people stop smoking by reducing their nicotine cravings.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're taking cytisine or the dummy pill. This helps ensure fair results.

What kind of video messages will I receive?

The video messages are designed to give you extra support and motivation to quit smoking before and after your surgery.

How long do I need to be in the study?

Your participation in the study involves follow-up for a total of six months, with assessments at specific times during that period.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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