Autonomous nurse-led methadone delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque
  Bayonne, France 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 Recruiting
• CSAPA du Griffon, Oppelia Aria 69
  Villeurbanne, France 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

Study contacts

• Study coordinator: Benjamin ROLLAND, MD
• Email: Benjamin.rolland@chu-lyon.fr
• Phone: 4 37 915 072

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindfulness Text Messages to Support Medication Adherence and Pain Management

  This study tests whether daily reminder and mindfulness text messages can help people on medications for opioid use disorder with chronic pain stick to their treatment and better manage cravings and pain.

  Recruiting University of New Mexico · Albuquerque, New Mexico · NCT07711795

• Text reminders and mindfulness messages to support people taking opioid medications

  This project will test whether daily medication reminder texts plus up to six mindfulness messages per day help people taking medications for opioid use disorder stick to their medication and manage cravings, pain, and withdrawal.

  Recruiting University of New Mexico · Albuquerque, New Mexico · NCT07350148

• How ibogaine changes brain activity in opioid use disorder.

  This study will test whether ibogaine changes brain activity and symptoms in adults with moderate-to-severe opioid use disorder who are already planning legal treatment.

  Recruiting University of California, Irvine · Irvine, California · NCT07226570

• Personalized adaptive deep brain stimulation for severe opioid use disorder

  This study will test whether personalized deep brain stimulation guided by invasive brain mapping is safe and can reduce cravings and opioid use in adults with severe, treatment-resistant opioid use disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07214467

• Sparrow Link device to help with opioid withdrawal in hospitalized adults with OUD

  A wearable nerve-stimulation device is being tested to see if it can help reduce withdrawal symptoms in adults with opioid use disorder who are hospitalized and receiving standard care.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07079826

• Cannabidiol added to methadone or buprenorphine for opioid recovery

  This trial will test whether adding cannabidiol (CBD) to methadone or buprenorphine helps people with opioid use disorder reduce craving and stop using illicit opioids.

  Recruiting at 2 sites Phase 3 Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT06940674

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.