(ROAR) Reversal of opioid-induced respiratory depression with opioid antagonists - a pharmacokinetic pharmacodynamic modeling study in opioid naïve individuals and chronic opioid users under real-life conditions
This study, called ROAR, is investigating how certain medicines, called opioid antagonists, can help people who have breathing difficulties experienced after taking strong painkillers (opioids). We're studying how these 'reversal' medicines work in two groups: healthy volunteers and people who regularly use opioids. Our aim is to understand exactly how quickly and effectively these reversal medicines, like naloxone, can improve breathing. We will measure how much medicine is in the body and how this affects breathing, to gain a better understanding of how these important treatments can be used to help patients breathe normally again. This research is important for making sure these life-saving medicines are used in the best way possible.
At a glance
What is this study about?
Imagine someone takes a strong painkiller, like fentanyl, and it makes their breathing dangerously slow. This study is all about understanding how medicines called 'opioid antagonists' can quickly bring their breathing back to normal. Think of an antagonist as a 'reversal switch' for the effects of opioids. We're looking at patients who use opioids regularly and patients who are generally healthy, to see how these reversal medicines work in different people.
We'll be giving participants some strong painkillers and then, if needed, the reversal medicine. We will then carefully measure their breathing and also check the levels of both the painkiller and the reversal medicine in their body. By doing this, we can figure out exactly how effective the reversal medicine is and how quickly it starts to work. We want to understand things like how much of the reversal medicine is needed and how long its effects last.
This research is really important because it helps us learn how to best use these reversal medicines, such as naloxone, in real-life situations. This knowledge can ultimately help medical professionals use them more effectively to save lives and ensure patients recover safely if they experience breathing problems due to strong painkillers.
Key takeaways
- Researches how medicines reverse dangerous breathing problems from strong painkillers.
- Compares how these reversal medicines work in healthy people versus opioid users.
- Aims to understand how quickly and effectively reversal medicines improve breathing.
- Uses advanced techniques to measure drug levels and breathing.
- Could improve how doctors use life-saving drugs for opioid overdose.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. Both men and women can take part.
We are looking for two main types of participants: healthy volunteers and people who currently have opioid use disorder. This means you might be considered if you are generally healthy and do not regularly take strong painkillers, or if you regularly use opioids.
Some things might mean you can't join, like having certain health conditions or taking specific medications, because we need to make sure the study is safe for everyone. The research team will ask you some questions to check if it's right 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?
- Are you willing to discuss your health history with the study team?
- Are you able to attend appointments at the study clinic?
- Are you generally healthy, or do you have a history of opioid use?
What does participation involve?
If you decide to take part, you will be invited to a clinic for a series of visits. During these visits, you'll be given a strong painkiller (like Fentanyl or Sufentanil) and we will closely monitor your breathing and other body functions. If your breathing becomes too slow, you will be given a 'reversal' medicine, such as Naloxone. While you are with us, we will regularly take small blood samples to measure the levels of these medicines in your body.
We will also take detailed measurements of your breathing throughout the study. The total time you spend participating in the study, including all visits and follow-up checks, will be explained fully by the study team. You will be monitored very closely by medical staff at all times to ensure your safety.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What are opioids?
Opioids are strong pain relievers, like morphine or fentanyl. They can be very effective but can also slow down your breathing, which can be dangerous.
What is an opioid antagonist?
An opioid antagonist is a medicine that blocks the effects of opioids. It can quickly reverse dangerous side effects, like very slow breathing, by kicking the opioid off the body's receptors.
Will I be given strong painkillers?
Yes, you will be given strong painkillers under very controlled conditions. This is so we can understand how the reversal medicines work to bring your breathing back to normal if it becomes too slow.
What is being measured in the study?
We are mainly measuring your breathing and taking blood samples to see how much of the medicines are in your body. This helps us understand how the medicines work.
Is this study safe?
Your safety is our top priority. You will be looked after by doctors and nurses for the whole time you are in the study, and they will watch you closely for any problems.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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