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MetAddon: Methadone as co-analgesic for patients with metastatic bone pain: a double-blind randomized controlled trial
EU CTIS ID: 2025-522710-22-00
What this study is testing
To assess whether methadone as add-on to already used (primairy) opioids is more effective in achieving a pain reduction in patients with metastatic bone pain compared to morphine.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients have metastatic bone pain reflected by a mean pain intesity score of ≥5 on an 11-point scale.
- Patients use strong opioids at a stable dose for at least seven days with a minimal daily dose of 60 mg MME (morphine milligram equivalence) (oxycodone SR 40 mg, fentanyl TD 25 mcg/hr, hydromorphine SR 12 mg).
- Patients are 18 years or older.
- Female patients of childbearing potential use contraceptives to prevent pregnancy during the study period.
You likely can't join if
- Patients who have prolonged QT syndrome.
- Patients who are scheduled for radiotherapy on bone lesions during the study period.
- Patients who have an indication for surgery to prevent pathological fractures.
- Patients who use irreversible monoamine oxidase (MAO) inhibitors within the last 14 days or during the study period.
- Patients who use enzalutamide in the last four weeks or during the study period.
- Patients who have myasthenia gravis.
See the full eligibility criteria
- Patients have metastatic bone pain reflected by a mean pain intesity score of ≥5 on an 11-point scale.
- Patients use strong opioids at a stable dose for at least seven days with a minimal daily dose of 60 mg MME (morphine milligram equivalence) (oxycodone SR 40 mg, fentanyl TD 25 mcg/hr, hydromorphine SR 12 mg).
- Patients are 18 years or older.
- Female patients of childbearing potential use contraceptives to prevent pregnancy during the study period.
- Patients who have prolonged QT syndrome.
- Patients who are scheduled for radiotherapy on bone lesions during the study period.
- Patients who have an indication for surgery to prevent pathological fractures.
- Patients who use irreversible monoamine oxidase (MAO) inhibitors within the last 14 days or during the study period.
- Patients who use enzalutamide in the last four weeks or during the study period.
- Patients who have myasthenia gravis.
- Patients who are pregnant.
- Patients who have a QTc-time > 500 ms (ECG max three months old).
- Patients with an eGFR < 30 mL/min (max. six weeks old).
- Patients who use buprenorphine, morphine SR or methadone.
- Patients who are not able to take oral medication.
- Patients who experience pain caused by a pathologic fracture or (suspected) nerve root compression.
- Patients who experience pain most likely not related to bone metastasis.
- Patients who have had surgery within seven days before the start of the study.
- Patients who received radiotherapy within the last six weeks on bone lesions.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.