Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04818086 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
A Phase 1 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04818086: Completed Phase 1 study, sponsored by Virginia Commonwealth University.
NCT04818086 is a Phase 1 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818086, a Phase 1 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
Primary Outcome
A finger pulse oximeter will be used to assess oxygen saturation (%). Change is calculated from the pulse oximetry readings from pre to post medication/placebo dose administered during the baseline study visit, this is a safety measure.
Interventions
- DRUG Placebo
- DRUG Lemborexant
- DRUG Buprenorphine-naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 1 |
What the finished NCT04818086 record still lists
NCT04818086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04818086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04818086 about?
NCT04818086 is a clinical study titled "Drug-drug Interaction Study of Lemborexant as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder". The purpose of this research study is to test the safety, tolerability, drug interactions with buprenorphine-naloxone, and effectiveness lemborexant when used to treat Opioid Use Disorder.
What is the current status of trial NCT04818086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-05-03. Estimated completion is 2023-04-20.
What interventions are being tested in trial NCT04818086?
The interventions under investigation include: Placebo (DRUG), Lemborexant (DRUG), Buprenorphine-naloxone (DRUG).
Who is sponsoring clinical trial NCT04818086?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04818086's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI