Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

MORPHINE PHARMACOKINETICS AND –DYNAMICS IN HEALTHY VOLUNTEERS AND PATIENTS WITH OBESITY AND OBSTRUCTIVE SLEEP APNOEA. -AN INVESTIGATOR INITIATED, CLINICAL STUDY OF THE IMPACT OF OBESITY AND SLEEP APNOEA ON THE PHARMACOLOGY OF MORPHINE

This research study, called 'Morphine and Sleep Apnoea', is exploring how a strong painkiller called morphine works in the body. We're especially interested in people who have obesity and obstructive sleep apnoea. These conditions can sometimes affect how medicines are processed. By comparing how morphine works in these individuals versus healthy volunteers, we aim to understand if these conditions change how much morphine stays in the body and for how long. This information is really important for doctors to know so they can give the right dose of morphine to manage pain safely and effectively for everyone, especially those with obesity and sleep apnoea.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sydvestjysk Sygehus

Enrolment target

140

Start

26 Sep 2022

Obesity and Obstructive Sleep apnoea

What is this study about?

This study is particularly looking at how a common strong painkiller, called morphine, behaves in the bodies of different people. Specifically, we're focusing on individuals who have two common health conditions: obesity (being very overweight) and obstructive sleep apnoea (where breathing repeatedly stops and starts during sleep).

When you take a medicine like morphine, your body processes it in various ways. Part of this study involves seeing how much morphine enters your bloodstream and how long it stays there. This is important because it directly affects how well the painkiller works and whether it might cause side effects. Scientists measure something called 'Area Under the Curve' (AUC) and 'Maximum Plasma Concentration' (CMAX) – these are just ways of measuring how much of the drug is in your body over time.

We also want to understand how sensitive people are to pain. To do this, we'll use some simple tests, like feeling heat, cold, or gentle pressure on muscles or bones. This helps us see if obesity and sleep apnoea also affect how people experience pain and how morphine might change that. By gathering this information, our goal is to help doctors better understand how to prescribe morphine safely and effectively for pain relief in all patients, including those with obesity and sleep apnoea.

Key takeaways

This study investigates how morphine works in people with obesity and sleep apnoea.
It aims to make morphine use safer and more effective for these patient groups.
Participation involves receiving small doses of medications and undergoing sensory tests.
Researchers will check how morphine levels change in your body over time.
The study includes healthy volunteers as well as those with obesity and sleep apnoea.

Who may be eligible?

This study is looking for both healthy volunteers and people diagnosed with obesity and obstructive sleep apnoea. To take part, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to participate in this research.

More specific details about your health will be discussed before you can join to make sure the study is safe for you. This might include checking for other health conditions or medicines you are currently taking.

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 have a diagnosis of obesity?
Do you have a diagnosis of obstructive sleep apnoea?
Are you comfortable with receiving medications and having blood tests?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive small doses of different medications under careful medical supervision. These include morphine, which is a painkiller, and naloxone, which can reverse the effects of morphine, as well as lidocaine, a local anaesthetic. You will also have some simple tests to see how sensitive you are to different types of sensations, such as heat, cold, and pressure on your muscles and bones. We will take blood samples to measure how much morphine is in your body over time. The study will involve several visits to a clinic and will be spread out over a period of time. You will be fully informed about the schedule and all procedures before committing to the study.

Potential risks and benefits

Taking part in this study could help us learn more about how to use morphine safely and effectively for pain relief in people with obesity and sleep apnoea, which may benefit future patients. As with any medical study, there are potential risks, such as temporary side effects from the medications given or discomfort from blood tests and sensory assessments. All procedures will be closely monitored by medical professionals to ensure your safety. 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
Denmark

Common questions

What is morphine?

Morphine is a strong painkiller used to treat moderate to severe pain. It belongs to a group of medicines called opioids.

What is obstructive sleep apnoea?

Obstructive sleep apnoea is a condition where your breathing repeatedly stops and starts while you sleep, often due to a blockage in the airway.

Will I be given morphine in this study?

Yes, you will receive small, controlled doses of morphine, as well as other medications like naloxone and lidocaine, under strict medical supervision.

What are 'sensory tests'?

These are simple tests where we'll gently check how you feel things like heat, cold, or light pressure on your skin, muscles, or bones. They help us understand your pain sensitivity.

Will I be paid for taking part?

The information provided does not specify payment, but it's common for studies to offer compensation for your time and travel. This is a good question to ask the study team.