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The dual orexin receptor antagonist daridorexant as an adjunct to improve buprenorphine maintenance therapy of opioid use disorder

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517482-16-00
Acronym
BUDA
Enrollment
192
Registered
2024-11-26
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder [OUD]

Brief summary

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

Detailed description

Retention in treatment (survival), Opioid craving (OC-VAS; weekly), Opioid withdrawal (Subjective Opioid Withdrawal Scale, SOWS [weekly]), Substance-related problem severity and associated service needs (Addiction Severity Index, validated Swedish Self-report version, ASI-SR]) [monthly], Sleep quality (Pittsburgh Sleep Quality Index: PSQI) [weekly], Insomnia Severity Index (ISI]) [monthly], Level of functioning (WHODAS) [monthly]

Interventions

DRUGFilm coated tablets matched to the test product as specified further in uploaded documents

Sponsors

Linkopings Universitet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Retention in treatment (survival), Opioid craving (OC-VAS; weekly), Opioid withdrawal (Subjective Opioid Withdrawal Scale, SOWS [weekly]), Substance-related problem severity and associated service needs (Addiction Severity Index, validated Swedish Self-report version, ASI-SR]) [monthly], Sleep quality (Pittsburgh Sleep Quality Index: PSQI) [weekly], Insomnia Severity Index (ISI]) [monthly], Level of functioning (WHODAS) [monthly]

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026