Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Results posted: Oct 20, 2026
    • Enrollment target: 138 to 249
    • Eligibility criteria expanded, about 21 words
    • Primary endpoints revised (3)
  2. Re-verified, no change to tracked fieldsv17
  3. Trial status: Recruiting to Completed
    • Enrollment target: estimated 200 to confirmed 138
    • Primary and study completion dates changed from estimate of Aug 2026 to Aug 15, 2025
    • Site details revised at 5 of 5 sites
    v16
  4. Primary and study completion dates: Aug 2025 to Aug 2026v15
  5. Primary and study completion dates: Aug 2024 to Aug 2025v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary and study completion dates: Nov 2024 to Aug 2024v13
  2. Primary and study completion dates: Nov 2023 to Nov 2024v12
  3. Re-verified, no change to tracked fieldsv11
  4. Eligibility criteria expanded, about 1 wordv10
  5. Re-verified, no change to tracked fieldsv9
  6. Study sites: 4 to 5
    • Eligibility criteria revised
    v8
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2020 to Nov 20, 2020
    • Eligibility criteria revised
    • Site details revised at 4 of 4 sites
    v7
  8. Primary and study completion dates: Oct 2023 to Nov 2023
    • Start date: Oct 2020 to Nov 2020
    v6
  9. Primary and study completion dates: Sep 2023 to Oct 2023
    • Start date: Sep 2020 to Oct 2020
    v5
  10. Primary and study completion dates: Aug 2023 to Sep 2023
    • Start date: Aug 2020 to Sep 2020
    v4
  11. Primary and study completion dates: Jul 2023 to Aug 2023
    • Start date: Jul 2020 to Aug 2020
    v3
  12. Start date: May 2020 to Jul 2020v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.
Trial Details
NCT Number NCT04287062
Lead Sponsor Johns Hopkins University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Sleep Disturbance, Opioid-use Disorder
Related terms Opioid-Related Disorders, Parasomnias
Enrollment 249 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov