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NCT03996694 · ClinicalTrials.gov registry record · Phase 1
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
A Phase 1 study, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03996694: Completed Phase 1 study, sponsored by BioDelivery Sciences International.
NCT03996694 is a Phase 1 study that has completed, run by BioDelivery Sciences International. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996694, a Phase 1 study, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreational users. This study will consist of a screening phase, treatment phase (which includes the Naloxone Challenge test) and follow-up visit.
Primary Outcome
Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo.
Interventions
- DRUG Belbuca 300 µg
- DRUG Belbuca 600 µg
- DRUG Belbuca 900 µg
- DRUG Oxycodone 30 mg
- DRUG Oxycodone 60 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2019-10-27 |
| Phase | Phase 1 |
What the finished NCT03996694 record still lists
NCT03996694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Belbuca 300 µg is the first listed.
NCT03996694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03996694 about?
NCT03996694 is a clinical study titled "Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.". The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users. This is a single-center, double -blind, double-dummy , placebo-controlled randomized crossover study in up to 18 men and women self identifying as recreati...
What is the current status of trial NCT03996694?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-07-23. Estimated completion is 2019-10-27.
What interventions are being tested in trial NCT03996694?
The interventions under investigation include: Belbuca 300 µg (DRUG), Belbuca 600 µg (DRUG), Belbuca 900 µg (DRUG), Oxycodone 30 mg (DRUG), Oxycodone 60 mg (DRUG).
Who is sponsoring clinical trial NCT03996694?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03996694's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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
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