Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04287062
The ClinicalTrials.gov registry entry for NCT04287062 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT04287062 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.