Autonomous Methadone Delivery System by Nurses

NCT07085377 | Recruiting

• 1 other identifier: 69HCL23_0905
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 8

Brief Summary

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

Opioid Use Disorder (OUD); Addictology

Keywords

Opioid use disorder (OUD); Methadone; Autonomous nursing system medication delivery; Nursing Care Delivery System

Outcome Measures

Primary Outcomes (1)

• Patient retention in care

  Patient retention in care at 3 months, defined as the last two methadone dispensing appointments honored in the 15 days preceding the end of the study (3 months), in the absence of a documented situation that prevented the patient from honoring his appointments (death, hospitalization, etc.).

  3 months

Secondary Outcomes (17)

• Euroqol EQ-5D 5 (EuroQol-5 Dimensions, 5 Levels Questionnaire) score

  3 months

• Medical cost of each strategy (DIADEME and Controle strategy)

  3 months

• Opioid withdrawal

  At 2 and 3 months

• CSQ-8 (Client Satisfaction Questionnaire) score

  3 months

• Total methadone doses

  over the 3-month follow-up period

Study Arms (3)

Patient DIADEME group

EXPERIMENTAL

The patient DIADEME group corresponds to the autonomous nursing system for managing the dispensing of methadone. This standardized protocol, in line with best practice guidelines, enables doses to be adjusted by nurses on the basis of a clinical assessment scheme incorporating the state of opioid withdrawal and overdosing.

Procedure: DIADEME strategy; Procedure: Individual semi directive interview

Patient control group

OTHER

The patient control group is managed in accordance with standard practice guidelines for patients with OUD, with care pathway provided by the hospital practictioner, assisted by nursing team.

Procedure: Controle strategy

Healthcare professionals group

OTHER

Focus groups with healthcare professionals will be held in each CSAPA after the last patient has been included in the center. Each focus group will consist of 6 to 8 professionals, including nurses and doctors involved in implementing the care protocol

Procedure: Individual semi directive interview

Interventions

DIADEME strategy PROCEDURE

This strategy consists of implementing the standardized DIADEME protocol. It, in line with best practice recommendations, enables nurses to adjust methadone dosage on the basis of a clinical assessment scheme incorporating opioid withdrawal and overdosing and includes: * initial medical consultation with the hospital practitioner for an addictology and psychiatry assessment, OUD assessment, and initial prescription of methadone for 3 months * ECG prior to any methadone prescription, hepatitis B, C, HIV testing may be offered, and an emergency NALOXONE kit will be given to the patient or prescribed * follow-up consultations with an nurse at least every 7 days, and more frequently if necessary.Dosages can be adjusted by the nurse on the basis of the standardized DIADEME protocol * medical consultation are only in the event of major withdrawal symptoms or overdosing or in the event of any incident not covered by the protocol and warranting rapid medical advice or at the patient's request

Patient DIADEME group

Controle strategy PROCEDURE

The control strategy corresponds to standard practice guidelines for patients suffering from drug addiction, with the care pathway provided by the hospital practitioner, assisted by the nursing team.

Patient control group

Individual semi directive interview PROCEDURE

Individual semi-directive interviews with a sample of patients from the DIADEME group (2 to 3 volunteer patients per CSAPA for a total of 20 to 30 interviews) will be conducted by a research psychologist and carried out at one month after the end of follow-up (3 months). Themes covered will include: commitment to care, patient/professional relationship, understanding of follow-up and treatment, experience of care and services at the addictology center, satisfaction with services received, level of response to expectations). Individual semi-directive interviews with a sample of healthcare professionals focus group will be also conducted by a research psychologist and carried out after the last patient has been included in the center. The aim will be to understand the effects of the intervention and identify its impact on professionals and the organization of the centers.

Healthcare professionals group; Patient DIADEME group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (8)

CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

NOT YET RECRUITING

CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

CSAPA de Brioude

Brioude, 43100, France

NOT YET RECRUITING

CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidence Le Victor Hugo

Le Puy-en-Velay, 43000, France

NOT YET RECRUITING

CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, 69003, France

RECRUITING

CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon

Lyon, 69004, France

NOT YET RECRUITING

CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg

Strasbourg, 690910, France

NOT YET RECRUITING

CSAPA du Griffon, Oppelia Aria 69

Villeurbanne, 69100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Benjamin ROLLAND, MD

CONTACT

4 37 915 072; Benjamin.rolland@chu-lyon.fr

William COSTES, Nurse

CONTACT

437117 852; William.costes@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter prospective open-label randomized (patient), controlled superiority trial, in two parallel-group

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 25, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): April 8, 2028
• Study Completion (Estimated): April 8, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

FR (8)