Autonomous nurse-led methadone delivery
Autonomous Methadone Delivery System by Nurses
NA · Hospices Civils de Lyon · NCT07085377
This test sees if allowing nurses to manage and give methadone helps people starting treatment for opioid use disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 8 sites (Bayonne and 7 other locations) |
| Trial ID | NCT07085377 on ClinicalTrials.gov |
What this trial studies
Adults starting methadone treatment at participating French CSAPA centers are assigned to either the DIADEME autonomous nursing delivery strategy or to a control strategy. Under the DIADEME approach, trained CSAPA nurses deliver methadone on site and may adapt doses according to a pre-approved team protocol and medical validation, while all participants receive regular semi-structured interviews. Participants are followed for three months to document medication delivery, adherence, safety, and care trajectories. The trial builds on recent French regulatory changes that expand nurse roles to test feasibility and acceptability of nurse-managed initiation and delivery.
Who should consider this trial
Good fit: Adults (18+) with opioid use disorder who plan to start methadone in a participating CSAPA within seven days and agree to three months of follow-up are ideal candidates.
Not a fit: People who received methadone by prescription in the prior three months, those with unstable psychiatric or cognitive disorders, pregnant or breastfeeding people, those unable to communicate in French, or those planning early transfer to another prescriber or pharmacy are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could make methadone initiation easier to access and allow nurses to safely manage treatment, potentially improving continuity of care.
How similar studies have performed: Nurse-led or task-shifting models for opioid treatment are relatively novel in France with limited published evidence, though similar approaches in other settings have shown mixed but sometimes promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, Exclusion Criteria: * 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 this trial is running
Bayonne and 7 other locations
- CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque — Bayonne, France (NOT_YET_RECRUITING)
- CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux — Bordeaux, France (NOT_YET_RECRUITING)
- CSAPA de Brioude — Brioude, France (NOT_YET_RECRUITING)
- CSAPA, Association Nationale de Prévention en Alcoologie et Addictologie (ANPAA), Résidence Le Victor Hugo — Le Puy-en-Velay, France (NOT_YET_RECRUITING)
- CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon — Lyon, France (RECRUITING)
- CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon — Lyon, France (NOT_YET_RECRUITING)
- CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
- CSAPA du Griffon, Oppelia Aria 69 — Villeurbanne, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Benjamin ROLLAND, MD
- Email: Benjamin.rolland@chu-lyon.fr
- Phone: 4 37 915 072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Addictology, Opioid use disorder, Methadone, Autonomous nursing system medication delivery, Nursing Care Delivery System