Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07085377

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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