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NCT04287062 · ClinicalTrials.gov registry record · Phase 2
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT04287062: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT04287062 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 138 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04287062, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Interventions
- DRUG Placebos
- DRUG Suvorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2025-08-15 |
| Phase | Phase 2 |
What the finished NCT04287062 record still lists
NCT04287062 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04287062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04287062 about?
NCT04287062 is a clinical study titled "Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder". 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,...
What is the current status of trial NCT04287062?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2020-11-20. Estimated completion is 2025-08-15.
What interventions are being tested in trial NCT04287062?
The interventions under investigation include: Placebos (DRUG), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT04287062?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04287062's enrollment target sits among peer trials
138 525th of 2000 higher than 1,474 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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