Autonomous Methadone Delivery System by Nurses

NANot yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Opioid Use Disorder (OUD)Addictology
Interventions
PROCEDURE

DIADEME strategy

"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"

PROCEDURE

Controle strategy

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.

PROCEDURE

Individual semi directive interview

"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."

Trial Locations (8)

33000

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

43000

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

43100

CSAPA de Brioude, Brioude

64109

CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque, Bayonne

69003

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

69004

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

69100

CSAPA du Griffon, Oppelia Aria 69, Villeurbanne

690910

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

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT07085377 - Autonomous Methadone Delivery System by Nurses | Biotech Hunter | Biotech Hunter