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RECRUITING Phase 2

Extended-release Buprenorphine as a Novel Low-dose Induction Strategy

NCT06441604 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Extended-release Buprenorphine

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital — Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-10-27
Est. Completion 2026-07-31
Phase Phase 2

Sponsor

Brigham and Women's Hospital

929 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06441604

The ClinicalTrials.gov registry entry for NCT06441604 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 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 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06441604 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06441604?

The interventions under investigation include: Extended-release Buprenorphine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06441604?

This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial