Actively Recruiting
Autonomous Methadone Delivery System by Nurses
Led by Hospices Civils de Lyon · Updated on 2025-12-16
182
Participants Needed
8
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Initiations of methadone treatment for opiode use disorder (OUD) are carried out in France in specialized centers, known as centers for care, support and prevention in addictology (CSAPA) In this way, hospital practitioners initiate the prescription of methadone, which is delivered on the spot by the nursing team. CSAPA nurses, and addictology nurses more generally, have a real range of skills which can include adapting treatment doses according to a protocol pre-established in a team, and medically validated (French law no. 2019-774 of July 24, 2019 relating to the organization and transformation of the healthcare system). The methadone speciality used for initiation in CSAPAs is almost always the syrup form. The capsule form can only be used after one year's treatment, unless exceptionally authorized by the medical officer of the French National Health Insurance Fund. However, regulations stipulate that the prescription of methadone syrup must be renewed every fourteen days, which in theory means that a CSAPA doctor must see the patient at least twice a month to renew the prescription, throughout the entire course of treatment. In practice, medical resources are often not sufficient for patients to be seen by a doctor at such a rate. Numerous palliative organizations exist, though they remain poorly described and documented. In some centers, doctors focus primarily on initiations, and prescriptions for patients for whom "stability" has been achieved are sometimes renewed for longer periods than fourteen days, with nurses in charge of assessing whether this organization is suitable for the patient. The notion of stability varies significantly from one center to another, and may mean achieving a constant dose, stopping illicit opioid use, or other criteria more focused on the patient's psychosocial reintegration. By outlining the missions of Addictology nurses, and more specifically of CSAPA nurses, the investigators can define the essential skills required of nurses to carry out these missions. The main hypothesis of the DIADEME study is that semi-autonomous management of methadone treatment initiation by CSAPA nursing teams helps to reinforce adherence to care and thus improve retention rates in the 3 months following initiation.
CONDITIONS
Official Title
Autonomous Methadone Delivery System by Nurses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject 18 years of age or older
- Diagnosed with opioid use disorder (OUD) according to DSM-5 criteria, including other authorized psychoactive substance use
- Planning to start methadone treatment for OUD in a CSAPA center within 7 days
- Agreeing to be followed up in a CSAPA center for the next 3 months
You will not qualify if you...
- Methadone treatment prescribed in the three months before inclusion
- Receiving medical care in another addiction facility or involved in a day-hospital program
- Planned or requested referral to a town prescriber or pharmacy before 3 months
- Unstable psychiatric disorder or cognitive impairment that may affect treatment compliance
- Inability to communicate in French
- Under legal protection measures other than curatorship
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque
Bayonne, France, 64109
Not Yet Recruiting
2
CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux
Bordeaux, France, 33000
Not Yet Recruiting
3
CSAPA de Brioude
Brioude, France, 43100
Not Yet Recruiting
4
CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidence Le Victor Hugo
Le Puy-en-Velay, France, 43000
Not Yet Recruiting
5
CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, France, 69003
Actively Recruiting
6
CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon
Lyon, France, 69004
Not Yet Recruiting
7
CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg
Strasbourg, France, 690910
Not Yet Recruiting
8
CSAPA du Griffon, Oppelia Aria 69
Villeurbanne, France, 69100
Not Yet Recruiting
Research Team
B
Benjamin ROLLAND, MD
CONTACT
W
William COSTES, Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
3
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