Autonomous Methadone Delivery System by Nurses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2028-04-08

Brief Summary

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Initiations of methadone treatment for opiode use disorder (OUD) are carried out in France in specialized centers, known as centers for care, support and prevention in addictology (CSAPA) In this way, hospital practitioners initiate the prescription of methadone, which is delivered on the spot by the nursing team. CSAPA nurses, and addictology nurses more generally, have a real range of skills which can include adapting treatment doses according to a protocol pre-established in a team, and medically validated (French law no. 2019-774 of July 24, 2019 relating to the organization and transformation of the healthcare system).

The methadone speciality used for initiation in CSAPAs is almost always the syrup form. The capsule form can only be used after one year's treatment, unless exceptionally authorized by the medical officer of the French National Health Insurance Fund. However, regulations stipulate that the prescription of methadone syrup must be renewed every fourteen days, which in theory means that a CSAPA doctor must see the patient at least twice a month to renew the prescription, throughout the entire course of treatment.

In practice, medical resources are often not sufficient for patients to be seen by a doctor at such a rate. Numerous palliative organizations exist, though they remain poorly described and documented. In some centers, doctors focus primarily on initiations, and prescriptions for patients for whom "stability" has been achieved are sometimes renewed for longer periods than fourteen days, with nurses in charge of assessing whether this organization is suitable for the patient. The notion of stability varies significantly from one center to another, and may mean achieving a constant dose, stopping illicit opioid use, or other criteria more focused on the patient's psychosocial reintegration. By outlining the missions of Addictology nurses, and more specifically of CSAPA nurses, the investigators can define the essential skills required of nurses to carry out these missions.

The main hypothesis of the DIADEME study is that semi-autonomous management of methadone treatment initiation by CSAPA nursing teams helps to reinforce adherence to care and thus improve retention rates in the 3 months following initiation.

Detailed Description

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Conditions

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Opioid Use Disorder (OUD) Addictology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multicenter prospective open-label randomized (patient), controlled superiority trial, in two parallel-group

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient control group

The patient control group is managed in accordance with standard practice guidelines for patients with OUD, with care pathway provided by the hospital practictioner, assisted by nursing team.

Group Type OTHER

Controle strategy

Intervention Type PROCEDURE

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.

Healthcare professionals group

Focus groups with healthcare professionals will be held in each CSAPA after the last patient has been included in the center.

Each focus group will consist of 6 to 8 professionals, including nurses and doctors involved in implementing the care protocol

Group Type OTHER

Individual semi directive interview

Intervention Type PROCEDURE

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.

Patient DIADEME group

The patient DIADEME group corresponds to the autonomous nursing system for managing the dispensing of methadone. This standardized protocol, in line with best practice guidelines, enables doses to be adjusted by nurses on the basis of a clinical assessment scheme incorporating the state of opioid withdrawal and overdosing.

Group Type EXPERIMENTAL

DIADEME strategy

Intervention Type PROCEDURE

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

Individual semi directive interview

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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