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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). 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.
Primary Outcome
Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.
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 |
What the finished NCT03789214 record still lists
NCT03789214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03789214 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03789214's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 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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