AuthorisedTherapeutic use (Phase IV)Interventional

MetAddon: Methadone as co-analgesic for patients with metastatic bone pain: a double-blind randomized controlled trial

This research trial is called 'MetAddon' and it's for people with cancer where the pain has spread to their bones. Doctors want to see if adding a medicine called methadone to their usual pain relief works better than using morphine alone to help manage this type of pain. The study is comparing these two treatments to find out if one is more effective at reducing pain. Researchers will be looking at how much pain relief people get over a few days, as well as if there are any side effects. This is a thorough study to help doctors understand the best ways to keep people comfortable.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Universiteit Maastricht

Enrolment target

166

Start

20 Oct 2025

Cancer bone metastasis pain

What is this study about?

Many people with cancer find that the pain can spread to their bones. This can be very uncomfortable and impact daily life. Doctors are always looking for the best ways to help manage this pain so that people can feel more comfortable.

This study is designed to compare two different ways of helping with this pain. One approach uses a medicine called methadone alongside usual pain relief. The other uses morphine, which is a common pain relief medicine. Both methadone and morphine are strong pain medicines, and the study wants to see if using methadone might offer better or different pain relief for people with bone pain from cancer.

The main goal is to see if, after a few days, a higher number of people taking methadone experience a noticeable reduction in their pain, compared to those taking morphine. Researchers will also be checking other things like how intense the pain is each week, how quickly people get relief, how their general well-being changes, and if they need other medicines for sudden pain. They'll also be looking at any side effects people might experience, as well as how their quality of life is affected, to get a full picture of how each treatment works.

Key takeaways

This study compares methadone and morphine for cancer-related bone pain.
It aims to find out if methadone is more effective at reducing pain.
Participation involves taking study medication and keeping a pain diary for three weeks.
All adult patients with cancer bone pain are potentially eligible.
You will receive close medical monitoring throughout the study.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older. There is no upper age limit, which means people of all adult ages can take part.

Both men and women are welcome to participate in this study. The researchers want to include a wide range of people to make sure the results are helpful for many different patients.

To be considered, you would need to have cancer where the pain has spread to your bones. This study is specifically designed for people experiencing this type of pain.

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 cancer pain that has spread to your bones?
Are you able to follow study instructions and record information in a diary?
Are you willing for doctors to decide by chance whether you receive methadone or morphine?
Are you prepared to take study medication and be monitored for about three weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given either methadone or morphine, in addition to your current pain relief, but you wouldn't know which one you are receiving – this is decided by chance, like flipping a coin. For the main part of the study, you would take your study medication and keep track of your pain and any side effects in a diary over three weeks. You would regularly record your pain levels using a simple scale, and also note if you need any extra 'rescue' medication for sudden pain.

Throughout the study, you would answer questions about how you are feeling and your quality of life. There would be assessments at the start (called 'baseline'), and then regularly over the 21 days, including checking for any side effects. The total duration of your active participation in taking the study medicine and reporting would be about three weeks.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving close medical attention for your bone pain and trying a different approach to pain management that might work well for you. However, there are also potential risks, as both methadone and morphine can have side effects, which your doctor will discuss with you. You might experience common side effects like drowsiness, sickness, or constipation. Remember, your participation is completely 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.

—
Unverified
Netherlands

Common questions

What is the main purpose of this study?

The main purpose is to see if methadone works better than morphine for pain caused by cancer that has spread to the bones.

Will I know if I'm getting methadone or morphine?

No, you won't know. This is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until after the study is over.

How long will I be in the study?

The main treatment and reporting period for the study medication will last approximately three weeks.

Who can join this study?

Adults aged 18 or older, both men and women, who have pain from cancer that has spread to their bones.

What if I feel unwell during the study?

You will be closely monitored, and any side effects or complications will be recorded. You can discuss any concerns with your study team at any time.