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Search / Trial NCT07085377

Autonomous Methadone Delivery System by Nurses

Launched by HOSPICES CIVILS DE LYON · Jul 17, 2025

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Opioid Use Disorder (Oud) Methadone Autonomous Nursing System Medication Delivery Nursing Care Delivery System

ClinConnect Summary

This clinical trial is studying a new way to start methadone treatment for people with opioid use disorder (OUD), which means struggling with addiction to opioids like heroin or certain painkillers. Usually, doctors in special centers in France called CSAPAs begin methadone treatment and nurses give the medicine directly to patients. This study will look at whether letting nurses have more responsibility in managing the early stages of methadone treatment helps patients stick with their treatment better during the first three months.

To join the study, participants need to be adults (18 or older) who have been diagnosed with opioid use disorder and plan to start methadone treatment at a CSAPA center within a week. They must agree to follow up with the center for three months. People who have recently taken methadone, are receiving care elsewhere, have unstable mental health issues, or are pregnant or breastfeeding cannot join. If accepted, participants will receive methadone treatment managed closely by nurses, who will adjust care under a set plan to support patients. The goal is to see if this nurse-led approach helps people stay engaged with their treatment and improve their chances of recovery.

Gender

ALL

Eligibility 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.

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Bayonne, , France

Bordeaux, , France

Brioude, , France

Le Puy En Velay, , France

Lyon, , France

Lyon, , France

Strasbourg, , France

Villeurbanne, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported