RecruitingPHASE4INTERVENTIONAL

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

This study, for people living in Ontario, Canada, is trying a new way to help individuals quit smoking. It will test three approved stop-smoking medicines: Nicotine Replacement Therapy (like patches or gum), Cytisine, or Varenicline (also known as Champix). Participants will also get free online counselling and have their stop-smoking products sent directly to them from a pharmacy. The main goals are to see if people are willing to join such a program, how much of the products are used, if they are safe, and how effective this online approach is. There's also a group that won't receive the study medicines but will get free online coaching and support to help them quit. This first stage aims to enrol at least 150 participants.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

150

Start

30 Apr 2025

Estimated completion

30 Oct 2027

Tobacco

What is this study about?

This study is a new look at how we can help people in Ontario, Canada, stop smoking. It's called a 'vanguard' trial, which means it's one of the first of its kind, trying out a new approach.

The main idea is to offer everyone who joins free counselling and send approved stop-smoking medicines directly to their home through a virtual pharmacy. The medicines being looked at are a combination of nicotine patches and other nicotine products (like gum or lozenges), a medication called Cytisine, or another medication called Varenicline (you might know it as Champix). The researchers want to understand how well people use these products, if they are safe, and how useful the online counselling and home delivery are over a full year. They're especially interested in how this entirely online approach works.

There's also a group within the study who won't receive any of the study medications. Instead, they will get free online coaching and support to help them quit smoking. Everyone taking part, whether they receive medication or not, will be asked to fill out questionnaires to share their experiences. This study is important because it's testing a convenient, online way to reach many more people who want to quit smoking, which could make it easier for them to get the help they need.

Key takeaways

Tests three approved stop-smoking methods: NRT, Cytisine, or Varenicline (Champix).
Offers free online counselling and medicines delivered to your home.
This study is completely virtual; no clinic visits are needed.
Aims to find the most effective and accessible ways to help people quit smoking.
Open to adults aged 18+ in Ontario, Canada, who want to quit or reduce smoking.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and currently, live in Ontario, Canada. You should be smoking more than 5 cigarettes a day and genuinely interested in either cutting down or quitting smoking within the next six months. It's also important that you can understand the study information and agree to take part.

There are also some reasons why you might not be able to join. For example, if you've used any of the study medications (like NRT, Cytisine, or Champix) in the last seven days, or if you're already in another formal stop-smoking program. You also can't take part if you are pregnant or breastfeeding. The study team will need to make sure that the medicines are safe for you to take, so if you have certain health conditions that mean these medicines aren't suitable, you won't be able to join.

Finally, to make sure you can get the full benefit and complete the study, you'll need to be able to follow up regularly. This means if you have any conditions that would make it difficult for you to stay in touch or complete the study tasks, such as severe mental health issues, memory problems, or if you don't speak English or French, you might not be suitable.

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 live in Ontario, Canada?
Do you smoke more than 5 cigarettes a day?
Are you interested in cutting down or quitting smoking in the next 6 months?
Are you able to speak English or French and understand the study information?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for a full 12 months. Everyone will receive free, expert counselling sessions, which will be delivered online, so you won't need to travel. If you're in one of the medication groups, you'll also receive your chosen stop-smoking products delivered directly to your home via a virtual pharmacy.

The study team will regularly check in with you to see how you're doing, whether you're using the products as planned, and how many counselling sessions you attend. They'll also ask you questions about your smoking habits and general well-being through questionnaires. This is to help them understand how effective the different approaches are and how safe the medicines are for you. You won't need to visit a clinic in person for any part of this study.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You'll receive free, evidence-based stop-smoking medicines and professional online counselling, all delivered conveniently to your home. This support can greatly increase your chances of quitting smoking, which would improve your health and save you money in the long run. Like all medicines, the stop-smoking products have potential side effects, which will be explained to you in detail. There's also a chance you might spend some time filling out questionnaires. Your safety is very important, and you will be closely monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What kind of stop-smoking medicines are being tested?

The study is testing three approved options: combined Nicotine Replacement Therapy (NRT) like patches plus gum/lozenge, Cytisine, or Varenicline (Champix).

Do I have to pay for the counselling or medicines?

No, all counselling sessions and stop-smoking products provided as part of the study are completely free of charge for participants.

Where does the study take place?

This study is entirely virtual, meaning all support, counselling, and product delivery will happen online or through home delivery. You need to live in Ontario, Canada, to join.

What if I decide I don't want to continue with the study?

You are free to leave the study at any point, for any reason, without facing any penalties or affecting your future medical care.

Is there a group that doesn't get stop-smoking medicines?

Yes, there is an observational group that receives free online coaching and support but no study medication. They will still complete questionnaires.

How to find out more

Evyanne Quirouette

equirouette@ottawaheart.ca 613-696-7000 Official trial record

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