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NCT06441604 · ClinicalTrials.gov registry record · Phase 2
Extended-release Buprenorphine as a Novel Low-dose Induction Strategy
A Phase 2 study of Opioid Use Disorder, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06441604: Recruiting Phase 2 study of Opioid Use Disorder, sponsored by Brigham and Women's Hospital.
NCT06441604 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06441604, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study procedures over the course of 3 days. Participants will receive fentanyl to prevent the emergence of withdrawal. Each participant will then receive a single injection of XR-BUP after which study staff will monitor for any precipitated withdrawal.
Primary Outcome
The primary outcome is the proportion of participants who successfully complete induction, defined as experiencing no BPOW, which will be assessed using the COWS. An increase in the COWS score by 8 or more with the total score exceeding 13, within 4 hours will be considered BPOW.
Conditions Studied
Interventions
- DRUG Extended-release Buprenorphine
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What NCT06441604 shows while recruiting
NCT06441604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Extended-release Buprenorphine is the first listed.
NCT06441604 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06441604 about?
NCT06441604 is a clinical study titled "Extended-release Buprenorphine as a Novel Low-dose Induction Strategy". This is a clinical trial to characterize the safety and pharmacokinetics of using extended-release buprenorphine (XR-BUP) as a novel low-dose buprenorphine induction strategy. Individuals with a diagnosis of Opioid Use Disorder (OUD) (n=30) will be admitted to an inpatient unit to complete study pro...
What is the current status of trial NCT06441604?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2025-10-27. Estimated completion is 2026-07-31.
What conditions does trial NCT06441604 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06441604?
The interventions under investigation include: Extended-release Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT06441604?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06441604 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06441604's enrollment target sits among peer trials
30 205th of 257 higher than 46 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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