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NCT06023459 · ClinicalTrials.gov registry record · Phase 3
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
A Phase 3 study of Substance-Related Disorders and Opioid-Related Disorders, sponsored by Yih-Ing Hser.
- Active
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
- 7
- Study locations
NCT06023459 is a Phase 3 study of Substance-Related Disorders and Opioid-Related Disorders that is active but no longer recruiting, run by Yih-Ing Hser. The registered enrollment target is 144 participants, below the 1,519-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT06023459, a Phase 3 study of Substance-Related Disorders and Opioid-Related Disorders, is active but no longer recruiting, sponsored by Yih-Ing Hser.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
- 7
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,519-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (91% lower). The listed sponsor is Yih-Ing Hser, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06023459 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Arkansas, California, Illinois.
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.
What interventions are being tested in trial NCT06023459?
The interventions under investigation include: Injectable extended-release buprenorphine (DRUG), Sublingual buprenorphine-naloxone (DRUG).
Who is sponsoring clinical trial NCT06023459?
This trial is sponsored by Yih-Ing Hser, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
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