Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Comparison of multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity

This research study is investigating the effectiveness of naloxone, a medication used to quickly reverse the effects of opioid painkillers. The study is comparing two common ways naloxone can be given: as an injection into the muscle or under the skin, and as a nasal spray. The main goal is to find out how many doses of naloxone are needed with each method to reverse the effects of a strong painkiller called fentanyl in healthy volunteers. Researchers will also look at how quickly different body functions recover and how much naloxone and fentanyl are in the blood over time. This helps us understand which method works best and why.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leiden University Medical Center

Enrolment target

Start

14 Aug 2023

Healthy volunteers

What is this study about?

This study aims to understand how different forms of naloxone work when someone has too much opioid in their system. Opioids are strong pain medicines, and sometimes, if too much is taken, it can cause serious problems like difficulty breathing. Naloxone is a life-saving medication that can quickly reverse these effects.

The researchers are comparing two main ways to give naloxone: as an injection into a muscle or under the skin, and as a nasal spray, like the one many people are familiar with. They are giving a small, controlled amount of a strong painkiller called fentanyl to healthy volunteers and then using different naloxone products to see how effectively and quickly they reverse fentanyl's effects.

The main thing the doctors want to measure is how many doses of naloxone are needed to reverse the opioid's effects. They also want to see how quickly volunteers' breathing returns to normal, how much oxygen is in their blood, and how much naloxone and fentanyl are in their system at different times. They will also check things like pupil size and muscle tone. This information will help doctors understand the best way to give naloxone when it's needed most.

Key takeaways

This study compares injected and nasal naloxone for reversing opioid effects.
It uses healthy volunteers and a strong painkiller called fentanyl.
The main goal is to find out how many doses of naloxone are needed.
Researchers will also look at how quickly breathing and other body functions recover.
The findings will help improve how naloxone is used in real-life emergencies.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you must be 18 years old or older. There is no upper age limit for suitable participants. Both men and women are welcome to participate in this research.

The study is specifically designed for people who are in good general health. If you have any ongoing health conditions or are taking long-term medications, these will be carefully reviewed by the study team to ensure your safety and suitability for the study.

Because this study involves giving a strong painkiller (fentanyl) and then reversing its effects with naloxone, it's very important that participants are otherwise healthy and can safely undergo these temporary changes to their body.

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 in good health?
Are you a man or a woman?
Are you comfortable with receiving injections and nasal sprays?
Are you able to attend multiple visits to a study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a full health check-up to make sure it's safe for you. Over a period of time, you would visit the study clinic several times. During these visits, you would be given a small, controlled amount of a strong painkiller, fentanyl, and then different types and doses of naloxone (either by injection or nasal spray).

The study team would closely monitor you for several hours after each dose, checking things like your breathing, heart rate, and drug levels in your blood. You might also have your pupil size and muscle tone checked. The total duration of your participation, including all visits and follow-up, would be made clear to you by the study team.

Potential risks and benefits

Participating in research studies like this can help medical science learn more about how vital medicines, like naloxone, work best. This could, in turn, help improve care for others in the future. However, there are potential risks, such as temporary side effects from the medications given (like drowsiness or short-term discomfort from injections/nasal spray). The study team will explain all potential risks in detail, and your safety will be closely monitored throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 naloxone?

Naloxone is a medicine that quickly reverses the effects of strong painkillers like opioids, especially if someone has taken too much and is struggling to breathe.

What is fentanyl?

Fentanyl is a very strong opioid painkiller. In this study, a small, controlled amount is given to see how naloxone reverses its effects.

Will I become addicted to the painkiller?

No, a very small, controlled dose of fentanyl is used, and its effects are quickly reversed by naloxone. This study is not designed in a way that would lead to addiction.

What does 'healthy volunteers' mean?

It means the study is looking for people who are generally in good health and don't have any major medical conditions that could make taking part unsafe.

Can I leave the study if I change my mind?

Yes, you are free to stop participating in the study at any point, for any reason, and it will not affect your relationship with your doctors.