Autonomous Methadone Delivery System by Nurses

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder (OUD), Addictology

In brief

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.

Key facts

Study ID: NCT07085377
Run by: Hospices Civils de Lyon
People needed: 182
Starts: 2025-12-08
Expected to finish: 2028-04-08
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject 18 years of age or older,
With opioid use disorder (OUD) according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria (other authorized psychoactive substance use),
Intending to start methadone treatment for OUD in a CSAPA center within 7 days,
Agreeing to be followed up in a CSAPA over the next 3 months,

You may not qualify if…

Having taken methadone treatment (on prescription) in the three months prior to inclusion,
Simultaneous medical care in another addictology facility,
with a day-hospital project,
Referral to town prescriber or town pharmacy planned and/or requested by patient before 3 month,
Non-stabilized psychiatric disorder or cognitive impairment likely to compromise compliance and involvement in care (at investigator's discretion),
Inability to communicate and express themselves in French language,
Subject to a legal protection measure other than curatorship,
Pregnant or breast-feeding.

Where it is running

CSAPA du Griffon, Oppelia Aria 69 — Villeurbanne, France (enrolling)
CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon — Lyon, France (enrolling)
CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon — Lyon, France (enrolling)
CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque — Bayonne, France (enrolling)
CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg — Strasbourg, France
CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux — Bordeaux, France
CSAPA de Brioude — Brioude, France
CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidence Le Victor Hugo — Le Puy-en-Velay, France

Full record on ClinicalTrials.gov

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