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ACTIVE NOT RECRUITING Phase 3

Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

NCT06023459 · View on ClinicalTrials.gov ↗

Study Summary

This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.

Interventions

  • DRUG Injectable extended-release buprenorphine
  • DRUG Sublingual buprenorphine-naloxone

Study Locations (7)

Arkansas

  • AppleGate Recovery El Dorado — El Dorado

California

  • Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital — Garberville

Illinois

  • Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness — Gibson City

Maine

  • Penobscot Community Health Care Inc. - Seaport Community Health Center — Belfast

Oregon

  • Oregon Health & Science University Primary Care Clinic, Scappoose — Scappoose

Washington

  • Providence Northeast Washington Medical Group — Colville

West Virginia

  • New Beginnings Recovery Clinic & Behavioral Health Center — New Martinsville

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2024-10-14
Est. Completion 2026-02-28
Phase Phase 3

Sponsor

Yih-Ing Hser

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06023459

The ClinicalTrials.gov registry entry for NCT06023459 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yih-Ing Hser, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Substance-Related Disorders appearing as the primary indexed condition, and to 2 interventions — of which Injectable 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: NCT06023459 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Arkansas, California, Illinois. 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 NCT06023459 about?

NCT06023459 is a clinical study titled "Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)". This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to se...

What is the current status of trial NCT06023459?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2024-10-14. Estimated completion is 2026-02-28.

What conditions does trial NCT06023459 study?

This clinical trial studies the following conditions: Substance-Related Disorders, Opioid-Related Disorders, Narcotic-Related Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06023459?

The interventions under investigation include: Injectable extended-release buprenorphine (DRUG), Sublingual buprenorphine-naloxone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06023459?

This trial is sponsored by Yih-Ing Hser, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06023459 being conducted?

This trial has 7 study locations across Arkansas, California, Illinois, Maine, Oregon. 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