NCT07085377: DIADEME

Autonomous Methadone Delivery System by Nurses

Recruiting now NA Last updated 16 December 2025

What this trial tests

NA trial testing DIADEME strategy in Opioid Use Disorder (OUD) in 182 participants. Currently enrolling.

Timeline

8 December 2025

Primary endpoint
8 April 2028

8 April 2028

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	182
Start date	8 December 2025
Primary completion	8 April 2028
Estimated completion	8 April 2028
Sites	8 locations across France

Drugs / interventions tested

• DIADEME strategy
• Controle strategy
• Individual semi directive interview

Conditions studied

• Opioid Use Disorder (OUD) — all drugs for Opioid Use Disorder (OUD) →
• Addictology — all drugs for Addictology →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Opioid Use Disorder (OUD) or Addictology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.