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NCT03789214 · ClinicalTrials.gov registry record · Phase 2
Medical Management of Sleep Disturbance During Opioid Tapering
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT03789214: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT03789214 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03789214, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.
Interventions
- DRUG Placebo oral capsule
- DRUG Low Dose Suvorexant
- DRUG High Dose Suvorexant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2021-06-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03789214
The ClinicalTrials.gov registry entry for NCT03789214 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 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 3 interventions - of which Placebo oral capsule is the first listed.
NCT03789214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03789214 about?
NCT03789214 is a clinical study titled "Medical Management of Sleep Disturbance During Opioid Tapering". This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUV...
What is the current status of trial NCT03789214?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2019-07-01. Estimated completion is 2021-06-10.
What interventions are being tested in trial NCT03789214?
The interventions under investigation include: Placebo oral capsule (DRUG), Low Dose Suvorexant (DRUG), High Dose Suvorexant (DRUG).
Who is sponsoring clinical trial NCT03789214?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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