Autonomous Methadone Delivery System by Nurses

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder (OUD); Addictology

• Registration Number: NCT07085377
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-09-01
• Primary Completion: 2028-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient retention in care	3 months	Patient retention in care at 3 months, defined as the last two methadone dispensing appointments honored in the 15 days preceding the end of the study (3 months), in the absence of a documented situation that prevented the patient from honoring his appointments (death, hospitalization, etc.).

Secondary Outcome Measures

Name	Time	Method
Euroqol EQ-5D 5 (EuroQol-5 Dimensions, 5 Levels Questionnaire) score	3 months	The outcome criterion for cost-utility analysis is the number of quality-adjusted life years (QALYs) gained. QALYs will be estimated on the basis of responses to the Euroqol EQ-5D 5L scale.; The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions.; The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.; The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Medical cost of each strategy (DIADEME and Controle strategy)	3 months	Budgetary impact for funders of extending the system to all CSAPAs in France (if efficiency is demonstrated).; Costs of medical and nursing consultations, care for adverse events, i.e. consultations and hospitalizations, particularly in connection with OST misuse.
Opioid withdrawal	At 2 and 3 months	Opioid withdrawal is described as the declared absence of opioid use (excluding methadone) with negative urinary toxins (excluding methadone and degradation products)
CSQ-8 (Client Satisfaction Questionnaire) score	3 months	Patients' overall satisfaction with CSAPA is assesed using the CSQ-8 scale (Client Satisfaction Questionnaire) The CSQ-8 scale consists of 8 questions that assess aspects like quality of service, whether patients' needs were met, likelihood of recommending the program, and overall satisfaction. Patients are asked to rate statements on a 4-point scale and are invited to provide additional comments.
Total methadone doses	over the 3-month follow-up period	Total methadone doses delivered and related to follow-up time (mg er day) during the follow-up period
Overdose episode	At 1, 2 and 3 months	Proportion of occurrences of at least one overdose episode (assessed clinically and by monthly patient declaration)
Hospital admissions	At 1, 2 and 3 months	Proportion of all-cause hospital admissions (assessed on the basis of monthly patient declarations, or external data such as medical correspondence)
Adverse event	At 1, 2 and 3 months	Proportion of occurrence and number of adverse events and serious adverse events (reported and assessed at each clinical evaluation point)
Opiate withdrawal	At 1, 2 and 3 months	Proportion of patients with at least one moderate (\>25) to severe (\>36) opiate withdrawal assessed by the Clinical Opioid Withdrawal Scale (COWS)
Montgomery and Asberg Depression Rating Scale (MADRS) score	Between inclusion and 3 months	Changes in severity of depression is assessed using the Montgomery and Asberg Depression Rating Scale score (MADRS) The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely recognized clinical assessment tool designed to measure the severity of depressive episodes in patients with mood disorders.; The scale consists of ten items, each targeting a different aspect of depression such as apparent sadness, reported sadness, inner tension, sleep disturbances, appetite, concentration, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored on a scale from 0 to 6, with higher scores indicating more severe symptoms. This scoring system allows clinicians to quantify symptoms in a standardized manner, facilitating both the initial assessment of depression severity and the ongoing monitoring of therapeutic interventions.
State-Trait Anxiety Inventory (STAI) score	Between inclusion and 3 months	Changes in anxiety levels is assessed using the State-Trait Anxiety Inventory (STAI) scale.; The State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7.
Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score	Between inclusion and at 1, 2 and 3 months	Changes in cannabis use and use disorder is assesed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R) score. This questionnaire was designed for self-administration and is scored by adding each of the 8 items. Questions 1-7 are scored on a 0-4 scale. Question 8 is scored 0, 2 or 4.
Alcohol Use Disorders Identification Test (AUDIT-C)	Between inclusion and at 1, 2 and 3 months	Assess changes in alcohol dependence using the Alcohol Use Disorders Identification Test (AUDIT-C).
Nicotine Dependence Test (FAGERSTROM) score	Between inclusion and at 1, 2 and 3 months	Changes in nicotine consumption is assessed using the Nicotine Dependence Test (FAGERSTROM) scale.; The Fagerstrom Nicotine Dependence Test is designed to provide an ordinal measure of nicotine dependence related to smoking. It contains six items that assess quantity of cigarettes smoked, compulsion to smoke and dependence. It is useful for screening for nicotine dependence and for assessing severity, which can be used for treatment planning and prognostic judgments.The lower is the score, the lower is the level of dependence.
Use of psychostimulant	Between inclusion and at 1, 2 and 3 months	Assess the change in the proportion of psychostimulant use accurrence on patient declaration every month (if yes, type and frequency); Frequency will be measured by the following categories: daily consumption, several times/week, once/week, several times/month, 1 time/month
Fidelity of the DIADEME intervention	Up to 3 months	Quantitative indicators describing compliance with the protocol implemented in CSAPAs (compliance with DIADEME protocol, number of nursing visits, delays, treatment adaptations carried out, requests for medical advice)
Acceptability of the DIADEME intervention	Up to 3 months	Acceptability on the part of patients and professionals at participating centers, perceived effects of monitoring and adaptation of treatment by nursing staff, impact on patient care, professionals' perceptions of the new nursing role, obstacles and levers identified to sustain the intervention.

Trial Locations

Locations (8)

CSAPA, Association Bizia, Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

CSAPA, Service d'Addictologie, Centre Hospitalier Charles Perrens, CHU de Bordeaux; 🇫🇷 Bordeaux, France

CSAPA de Brioude; 🇫🇷 Brioude, France

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

CSAPA, Service Universitaire d'Addictologie de Lyon, Hôpital Edouard Herriot, Hospices Civils de Lyon; 🇫🇷 Lyon, France

CSAPA, Hôpital de la Croix Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France

CSAPA, Service de Psychiatrie et d'Addictologie, Hôpital Civil, CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CSAPA du Griffon, Oppelia Aria 69; 🇫🇷 Villeurbanne, France