Daridorexant for Opioid use disorder

Inclusion criteria

• {"criterion_text":"- Men and women aged 20 - 65 years\n- 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.\n- ≥1 year duration of OUD\n- 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.\n- 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.\n- Able to speak and read Swedish.\n- Willing to provide informed consent."}

Exclusion criteria

• {"criterion_text":"- Patients with any serious psychiatric condition unless stable under treatment.\n- Patients already in OMT with a depot formulation of buprenorphine.\n- Patients enrolled in OMT with methadone\n- Patients with severe respiratory insufficiency\n- Patients with a diagnosis of narcolepsy\n- Patients with any other serious medical condition, unless stable under treatment.\n- Patients with concomitant use of strong CYP3A4 inhibitors (see Appendix 1 of protocol)\n- Women who are pregnant or plan on becoming pregnant, or who are nursing.\n- 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.\n- 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."}

Primary endpoints

• {"endpoint_text":"- Frequency of negative urine samples (obtained weekly, with missing samples coded as positive) throughout weeks 1-13, supported by Time-Line Follow-Back (TLFB) self-report","definition_or_measurement_approach":"Weekly urine samples collected during weeks 1-13; missing samples are coded as positive. Results supported by Time-Line Follow-Back (TLFB) self-report."}

Secondary endpoints

• {"endpoint_text":"- Retention in treatment (survival)","definition_or_measurement_approach":"Retention assessed by survival analysis / time-to-event methods (retention in treatment)."}
• {"endpoint_text":"- Opioid craving (OC-VAS; weekly)","definition_or_measurement_approach":"Opioid craving measured weekly using the OC-VAS instrument."}
• {"endpoint_text":"- Opioid withdrawal (Subjective Opioid Withdrawal Scale, SOWS [weekly])","definition_or_measurement_approach":"Opioid withdrawal measured weekly using the Subjective Opioid Withdrawal Scale (SOWS)."}
• {"endpoint_text":"- Substance-related problem severity and associated service needs (Addiction Severity Index, validated Swedish Self-report version, ASI-SR]) [monthly]","definition_or_measurement_approach":"Measured monthly using the validated Swedish self-report version of the Addiction Severity Index (ASI-SR)."}
• {"endpoint_text":"- Sleep quality (Pittsburgh Sleep Quality Index: PSQI) [weekly]","definition_or_measurement_approach":"Sleep quality measured weekly using the Pittsburgh Sleep Quality Index (PSQI)."}
• {"endpoint_text":"- Insomnia Severity Index (ISI]) [monthly]","definition_or_measurement_approach":"Insomnia severity measured monthly using the Insomnia Severity Index (ISI)."}
• {"endpoint_text":"- Level of functioning (WHODAS) [monthly]","definition_or_measurement_approach":"Level of functioning measured monthly using WHODAS."}

Methods

• Recruitment arrangements document uploaded (K1_Rekryteringsforfarande_2024-517482-16-00)
• Advertisements uploaded (K2_Annons_2024-517482-16-00; L2_Annons_2024-517482-16-00_version 2)

Sweden

Earliest CTIS Part Ii Submission Date

22-08-2024

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

536

Number Of Sites

7

Number Of Participants

192

Primary sponsor

Full Name

Linkopings Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Indivior (Auxilliary Medicinal Product)","duties_or_roles":"Auxilliary medicinal product (listed as monetary support)","organisation_type":""}
• {"country":"","full_name":"Idorsia (Investigational Medicinal Product and placebo)","duties_or_roles":"Provider of investigational medicinal product and placebo; listed as monetary/supporting organisation","organisation_type":""}
• {"country":"","full_name":"Region Östergötland","duties_or_roles":"Funding","organisation_type":""}