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The dual orexin receptor antagonist daridorexant as an adjunct to improve buprenorphine maintenance therapy of opioid use disorder
EU CTIS ID: 2024-517482-16-00
What this study is testing
To evaluate whether daridorexant can reduce illicit substance use compared compared to placebo, when provided as an adjuntive treatment to OUD patients maintained on depot buprenorphine.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men and women aged 20 - 65 years
- Meet criteria for moderate-to-severe OUD ”opioid dependence” according to ICD-10, confirmed using a checklist of DMS-5 criteria for OUD by a trained nurse or physician. Other, co-morbid substance use disorders will be evaluated by obtaining a history and carrying out a chart review; these will be confirmed using a checklist of DSM-criteria for the respective substance, and will be recorded, but will not influence eligibility except as specified below.
- ≥1 year duration of OUD
- Prospective participants will be eligible if they are not in stable remission, or if, despite being in stable remission from opioid use, they continue to use other substances in a manner that indicates they stand to potentially benefit from participating.
- Both patients not enrolled in OMT at the time of screening, and those with ongoing OMT with transmucosal buprenorphine formulations at that time will be eligible. Patients not currently enrolled in OMT will first be stabilized on transmucosal buprenorphine according to clinical routine.
- Able to speak and read Swedish.
You likely can't join if
- Patients with any serious psychiatric condition unless stable under treatment.
- Patients with any other condition or circumstances that, in the assessment of the investigator, lead to participation in the study not being in the best interest of the patient.
- Patients already in OMT with a depot formulation of buprenorphine.
- Patients enrolled in OMT with methadone
- Patients with severe respiratory insufficiency
- Patients with a diagnosis of narcolepsy
See the full eligibility criteria
- Men and women aged 20 - 65 years
- Meet criteria for moderate-to-severe OUD ”opioid dependence” according to ICD-10, confirmed using a checklist of DMS-5 criteria for OUD by a trained nurse or physician. Other, co-morbid substance use disorders will be evaluated by obtaining a history and carrying out a chart review; these will be confirmed using a checklist of DSM-criteria for the respective substance, and will be recorded, but will not influence eligibility except as specified below.
- ≥1 year duration of OUD
- Prospective participants will be eligible if they are not in stable remission, or if, despite being in stable remission from opioid use, they continue to use other substances in a manner that indicates they stand to potentially benefit from participating.
- Both patients not enrolled in OMT at the time of screening, and those with ongoing OMT with transmucosal buprenorphine formulations at that time will be eligible. Patients not currently enrolled in OMT will first be stabilized on transmucosal buprenorphine according to clinical routine.
- Able to speak and read Swedish.
- Willing to provide informed consent.
- Patients with any serious psychiatric condition unless stable under treatment.
- Patients with any other condition or circumstances that, in the assessment of the investigator, lead to participation in the study not being in the best interest of the patient.
- Patients already in OMT with a depot formulation of buprenorphine.
- Patients enrolled in OMT with methadone
- Patients with severe respiratory insufficiency
- Patients with a diagnosis of narcolepsy
- Patients with any other serious medical condition, unless stable under treatment.
- Patients with concomitant use of strong CYP3A4 inhibitors (see Appendix 1 of protocol)
- Women who are pregnant or plan on becoming pregnant, or who are nursing.
- Women of child-bearing potential will have to agree to practice reliable contraception (see Appendix 2 of protocol), or document that they intend to abstain from sexual intercourse.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.