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NCT06086275 · ClinicalTrials.gov registry record · Phase 1
Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT06086275: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT06086275 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. 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
NCT06086275, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or 16mg PO. The order for the first dose administered will be fixed to the IV dose, and the subsequent doses will be randomized and counterbalanced to 8mg or 16mg PO. Participants will be given naltrexone to produce opioid blockade to eliminate the risk for opioid dependence in individuals without OUD. Timed blood samples will be collected up to 24 hours.
Primary Outcome
The area under the plasma concentration curves (AUC) of buprenorphine will be determined. Timed blood samples will be collected in heparinized Vacutainer tubes via a catheter in the antecubital vein at baseline, and at 0.5, 1, 2, 4, 8, and 24 hours. Samples will be centrifuged and frozen until analysis.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 1 |
What the finished NCT06086275 record still lists
NCT06086275 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 1 intervention - of which Buprenorphine is the first listed.
NCT06086275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06086275 about?
NCT06086275 is a clinical study titled "Oral Buprenorphine as a Novel Low-dose Induction Strategy for Opioid Use Disorder". This is a human laboratory-based, randomized, cross-over study in which buprenorphine will be administered to healthy volunteers (n=22) in 3 separate inpatient 2-night visits, at least 1 week apart. At each visit, the participant will receive a single dose buprenorphine, either 0.15mg IV, 8mg PO, or...
What is the current status of trial NCT06086275?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-06-04. Estimated completion is 2025-10-01.
What interventions are being tested in trial NCT06086275?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT06086275?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06086275'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
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