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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 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 18 participants.
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.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06086275
The ClinicalTrials.gov registry entry for NCT06086275 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine is the first listed.
NCT06086275 reports 0 study locations.
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.
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