Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

L-NAC for reversal of opioid-induced respiratory depression

This research is investigating a medicine called L-NAC to see if it can help people recover from breathing difficulties caused by strong pain relievers, such as fentanyl. Sometimes, these pain medications can slow down breathing too much. The study wants to find out if L-NAC can safely reverse this effect, helping people to breathe more effectively. This study is for healthy adult volunteers. Researchers will be carefully measuring how much air volunteers breathe in and out, as well as checking oxygen and carbon dioxide levels in their blood. They’ll also look at how much of the medicines are in the blood. This information will help doctors understand if L-NAC could be a useful way to improve breathing for patients after receiving strong pain medication.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Leiden University Medical Center

Enrolment target

Start

12 May 2023

none healthy subjects only

What is this study about?

Imagine you're having a medical procedure or have severe pain, and doctors give you a strong painkiller like fentanyl. While these medicines are excellent for pain relief, a known side effect can be that they slow down your breathing, sometimes making it difficult.

This study is looking at a medicine called L-NAC (you might have heard of it in other contexts, but here it's being tested for a new use) to see if it can help your body get your breathing back to normal more quickly and safely after receiving such pain medication. The main aim is to see if L-NAC can increase the amount of air you breathe in and out each minute, which is a key sign of healthy breathing.

Researchers will also be checking other important things. They’ll measure the amount of carbon dioxide in your breath, how often you breathe, and how much air your lungs hold with each breath. They will also do some blood tests to check your oxygen levels and how much of the study medicines are in your system. This helps them understand exactly how L-NAC works and if it's a safe and effective treatment to help improve breathing difficulties caused by strong painkillers.

Key takeaways

This study tries to find a way to help people breathe better after strong painkillers.
It uses a medicine called L-NAC to see if it can reverse slow breathing.
Only healthy adults aged 18 and over can take part.
Participants will receive pain medication and then L-NAC or a dummy treatment.
Your breathing and blood will be carefully monitored throughout the study.

Who may be eligible?

To be able to join this study, participants must be generally healthy individuals. This means you shouldn't have any significant medical conditions that might affect the study results or your safety.

The study is open to both men and women.

Participants need to be 18 years old or older. There is no upper age limit, meaning as long as you are healthy, you can take part if you are 18 or older.

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 generally healthy with no serious medical conditions?
Are you able to commit to the study visits and monitoring schedule?
Are you willing to receive different medications, including a strong painkiller?
Are you comfortable with blood tests and wearing monitoring devices?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study clinic where you'll receive the pain medication (fentanyl) and then either L-NAC or a dummy treatment (a saline solution) which looks the same. Doctors and nurses will be closely monitoring your breathing, heart rate, and other vital signs throughout. This will involve wearing monitors and having blood samples taken at various times. The exact number of visits and the total duration of your participation will depend on the study design, but it will involve careful, supervised monitoring for a period after receiving the medications.

Potential risks and benefits

Potential benefits of taking part in research include contributing to medical knowledge that could help future patients. While there isn't a direct personal health benefit expected for individual healthy volunteers in this study, you will receive close medical monitoring. Potential risks might include discomfort from injections or blood tests, or temporary side effects from the medications given, such as drowsiness from fentanyl. All known risks will be fully explained before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is fentanyl?

Fentanyl is a strong pain-relieving medicine often used in hospitals for severe pain or during operations. It can sometimes make breathing slow down.

What is L-NAC?

L-NAC (or N-acetylcysteine) is a medicine that's been used for various things, and in this study, researchers are testing if it can help improve breathing that’s been slowed by strong pain medication.

Will I get both fentanyl and L-NAC?

Yes, you will receive fentanyl. Then, you will either receive L-NAC or a dummy treatment (a simple salt water solution) to see if L-NAC makes a difference to your breathing.

What does 'healthy subjects only' mean?

It means the study is looking for people who don't have any major ongoing health problems, to make sure any effects seen are due to the study medications and not other illnesses.

Will I be paid to take part?

Payment for participation varies between studies. This would be clearly discussed with you before you agree to take part.