Aggressive Smoking Cessation Trial (ASAP)
This research, called the ASAP Trial, aims to find the best way to help people with heart problems stop smoking. We know that stopping smoking is vital for heart health, but it can be very hard. This study will compare two approaches: a stop-smoking tablet (varenicline) combined with nicotine e-cigarettes, against the tablet on its own. Both groups will also receive counseling. We want to see how well these methods help people quit, how safe they are, and if they have any side effects. This 5-year study wants to find a more effective way to help people with heart conditions stay smoke-free.
At a glance
What is this study about?
If you have a heart condition and currently smoke, you're probably aware of how important it is to stop. Continuing to smoke can significantly increase your risk of further heart problems. While there are treatments available to help you quit, sometimes they aren't enough to help people stay smoke-free long-term. This study is looking into whether combining a well-known stop-smoking tablet called varenicline (you might know it as Champix) with nicotine e-cigarettes could be a more successful approach than using the tablet alone.
The ASAP Trial is a large, 5-year study based in several hospitals. We're inviting people who smoke and have a higher risk of heart problems to take part. The main aim is to see if this combination therapy (tablet plus e-cigarettes) works better for helping people quit smoking, and importantly, for staying quit over time. We also want to understand if this new combination is safe and easy to use, and if it causes any unwanted side effects.
The findings from this study could be really important. If combining these treatments proves to be more effective, it could offer a better chance for many people with heart conditions to stop smoking and significantly improve their long-term health. It's about finding a stronger way to help people overcome addiction and protect their hearts.
Key takeaways
- The study aims to find better ways to help people with heart conditions quit smoking.
- It compares a stop-smoking tablet plus e-cigarettes against the tablet alone, both with counselling.
- Participation involves 12 weeks of treatment and 52 weeks of follow-up.
- You must smoke at least 10 cigarettes daily and have a higher risk of heart problems.
- You can leave the study at any time without affecting your usual care.
- Results could help many people achieve long-term freedom from smoking.
Who may be eligible?
This study is looking for adult smokers aged 18 or over. You must smoke at least 10 cigarettes a day and be keen to stop smoking.
Crucially, you also need to have a higher risk of heart problems. This includes people who have recently been in hospital due to a heart attack or severe chest pain (unstable angina). It also includes people who are seeing their doctor for existing heart conditions, such as coronary artery disease, previous heart attacks, or who have had procedures like stents or bypass surgery.
We would also consider people with other conditions that increase heart risk, like kidney disease, a history of stroke, or problems with blood flow in their legs or neck. If you have some of these health issues and want to quit smoking, this study might be for you.
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 smoke at least 10 cigarettes a day?
- Are you motivated and ready to try and quit smoking?
- Have you recently been in hospital for a heart attack or severe chest pain?
- Do you have an existing heart condition, or other conditions that increase your heart risk?
- Are you able to attend regular appointments for about a year?
What does participation involve?
If you join the study, you'll be assigned to one of two groups by chance, like flipping a coin. You won't get to choose which group you're in, and neither will your doctors. One group will receive the stop-smoking tablet (varenicline) and nicotine e-cigarettes, along with counselling. The other group will receive just the stop-smoking tablet and counselling.
You'll take your study medication for 12 weeks. During this time, you'll have regular visits to check how you're doing, offer support, and monitor any side effects. After the 12 weeks of treatment, we'll continue to check in with you for another 40 weeks (making a total of 52 weeks, or about a year) to see if you've stayed smoke-free and how you're feeling. There will be assessments to confirm if you've stopped smoking.
Potential risks and benefits
Locations (13)
- Fraser Clinical TrialsVerified postcodeNew Westminster, Canada· Recruiting
- Dr. Georges-L.-Dumont University Hospital CenterVerified postcodeMoncton, Canada· Recruiting
- NL Health SciencesVerified postcodeSt. John's, Canada· Recruiting
- Queen Elizabeth II Health Sciences CenterVerified postcodeHalifax, Canada· Recruiting
- St. Joseph's HospitalVerified postcodeLondon, Canada· Recruiting
- University of Ottawa Heart InstituteVerified postcodeOttawa, Canada· Recruiting
- Sunnybrook Health Sciences CentreVerified postcodeToronto, Canada· Recruiting
- Montreal Heart InstituteVerified postcodeMontreal, Canada· Recruiting
- Centre Hospitalier de L'Universite de MontrealVerified postcodeMontreal, Canada· Recruiting
- Montreal General HospitalVerified postcodeMontreal, Canada· Recruiting
- Jewish General HospitalVerified postcodeMontreal, Canada· Recruiting
- Institut Universitaire de Cardiologie et de Pneumologie de QuébecVerified postcodeQuébec, Canada· Recruiting
Common questions
What is varenicline (Champix)?
Varenicline is a prescription medicine that helps people stop smoking by reducing cravings and withdrawal symptoms, and making smoking less enjoyable.
Are e-cigarettes safe?
While e-cigarettes are not risk-free, they are considered by many experts to be much less harmful than smoking regular cigarettes. This study aims to help understand their safety when combined with other treatments.
How long will the treatment last?
You will receive active treatment for 12 weeks, with follow-up appointments continuing for a total of 52 weeks (about a year) to see how you're doing.
Will I still get help if I'm in the group with just varenicline?
Yes, both groups will receive counselling and support to help you quit smoking, no matter which treatment plan you're on.
What if I experience side effects?
Your health will be closely monitored throughout the study, and the research team will provide support and guidance if you experience any side effects.
How to find out more
Tabitha Finch
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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