Autonomous Methadone Delivery System by Nurses for Opioid Use Disorder

What this Trial Is About

This research focuses on patients with opioid use disorder OUD who are starting methadone treatment. It evaluates whether allowing nurses in specialized addiction centers CSAPA to manage methadone initiation semi-autonomously helps improve patients adherence to care and retention in treatment over the first three months. The study compares this nursing-led approach to the standard care pathway where hospital doctors manage methadone prescriptions with nursing support. Participants are assigned to one of two groups the DIADEME group, where nurses adjust methadone doses based on a standardized clinical protocol including assessment of withdrawal and overdose symptoms, or the control group following usual practice with hospital doctors prescribing methadone. The DIADEME strategy includes an initial medical consultation, ECG and infection testing, provision of an emergency naloxone kit, and weekly or more frequent nurse follow-ups. Medical consultations occur only if serious issues arise or at the patients request. During the study, participants will be followed for three months with regular assessments of retention in care, opioid withdrawal symptoms, overdose episodes, hospital admissions, satisfaction, depression and anxiety scores, substance use, and methadone dosing. Healthcare professionals involved in the care will also participate in focus groups after patient enrollment ends. The study measures both patient outcomes and the acceptability and fidelity of the nurse-led intervention over three months.

Autonomous Methadone Delivery System by Nurses