RecruitingNAINTERVENTIONAL

Autonomous Methadone Delivery System by Nurses

This study, called DIADEME, is looking into new ways of starting and managing methadone treatment for opioid use disorder in France. Usually, doctors prescribe methadone, but their time can be limited. This trial is exploring if specially trained nurses in addiction centres (CSAPAs) can take on more responsibility in starting and adapting methadone doses, following clear medical guidelines. The main idea is that if nurses can manage these treatments more independently, it might help more people stay on their methadone and get better support in the first three months of treatment. They want to see if this approach improves how well people stick with their treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

182

Start

08 Dec 2025

Estimated completion

08 Apr 2028

Opioid Use Disorder (OUD)Addictology

What is this study about?

This study is about making it easier for people in France who have opioid use disorder (sometimes called opioid addiction) to get and stay on methadone treatment. Methadone is a medicine that helps manage cravings and withdrawal symptoms.

Currently, starting methadone treatment usually happens in special centres called CSAPAs, where doctors prescribe the medicine. However, doctors can be very busy, and regulations mean prescriptions often need frequent renewals. This can make it hard for everyone to see a doctor as often as needed.

This study looks at whether nurses in these CSAPA centres, who are highly skilled in addiction care, could play a larger role in starting and adjusting methadone treatment. They would still follow strict medical guidelines. The researchers believe that if nurses are more involved in managing the treatment, it could help people stay in care for longer and get the support they need, especially in the first three months.

Key takeaways

The study explores a new way for nurses to manage methadone treatment.
It aims to improve how people stick with their treatment for opioid use disorder.
Participation lasts for three months after starting methadone.
The study takes place in special addiction centres (CSAPAs) in France.
It focuses on improving timely support for patients.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with opioid use disorder. You should be planning to start methadone treatment in a CSAPA centre within the next week and be willing to continue your care there for the next three months.

However, you wouldn't be able to join if you've already had prescribed methadone treatment in the last three months. You also can't be in the study if you're getting addiction care somewhere else at the same time, or if you plan to get your methadone from a different doctor or pharmacy too soon.

Other reasons you might not be able to join include having a severe mental health condition that isn't stable, or if you can't speak French well enough to understand the study. Pregnant or breastfeeding women also cannot participate, nor can individuals under certain types of legal protection.

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?
Have you been diagnosed with opioid use disorder?
Are you planning to start methadone treatment in a CSAPA within 7 days?
Are you willing to stay in a CSAPA for care for the next 3 months?
Have you NOT taken prescribed methadone in the last 3 months?
Are you able to speak and understand French?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be starting methadone treatment for your opioid use disorder. The study will look at how your treatment is managed, specifically focusing on the role nurses play in it. You will attend a CSAPA centre for your treatment and follow-up appointments over a period of three months. This will involve regular check-ups and discussions about your progress and the effectiveness of the treatment. The main difference might be how often you see a doctor versus a nurse for your prescription and dose adjustments. The total duration of active participation in the study is three months, with ongoing methadone treatment management.

Potential risks and benefits

Participating in this trial might offer benefits like potentially getting more consistent and timely support for your methadone treatment in the crucial first three months. This could help you stay in treatment and improve your overall journey to recovery. However, as with any medical treatment, there could be individual risks associated with methadone itself, which your care team will discuss. You are always free to withdraw from the study at any time without affecting your standard medical care.

Locations (8)

CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque
Verified postcode
Bayonne, France· Not yet recruiting
CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CSAPA de Brioude
Verified postcode
Brioude, France· Not yet recruiting
CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidence Le Victor Hugo
Verified postcode
Le Puy-en-Velay, France· Not yet recruiting
CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon
Verified postcode
Lyon, France· Not yet recruiting
CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting
CSAPA du Griffon, Oppelia Aria 69
Verified postcode
Villeurbanne, France· Not yet recruiting

Common questions

What is opioid use disorder?

Opioid use disorder is a medical condition where a person has a strong urge to use opioid drugs and has difficulty controlling their use, even if it causes problems in their life.

What is methadone?

Methadone is a medication used to treat opioid use disorder. It helps reduce cravings and withdrawal symptoms, allowing people to focus on their recovery.

What is a CSAPA centre?

CSAPA stands for Centres for Care, Support, and Prevention in Addictology. These are special centres in France that provide help and treatment for people with addiction issues.

What will nurses do differently in this study?

In this study, nurses might take on a more active role in starting and adjusting methadone doses, following clear medical guidelines and working closely with doctors, to help reinforce consistent care.

How long will I be in the study?

You would be followed for three months after starting methadone treatment. Your overall methadone treatment would likely continue beyond this.

How to find out more

Benjamin ROLLAND, MD

benjamin.rolland@chu-lyon.fr 4 37 915 072 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.