Clinical trialNCT06023459CompletedPhase 3Interventional

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

SponsorYih-Ing HserEnrollment140Narcotic-Related DisordersOpioid-Related DisordersSubstance-Related Disorders

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Larissa Mooney, MD
University of California, Los Angeles
Principal Investigator
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Yih-Ing Hser, PhD
University of California, Los Angeles
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Applegate Recovery El Dorado
El Dorado, Arkansas, United States
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, United States
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, United States
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, United States
Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, United States
Providence Northeast Washington Medical Group
Colville, Washington, United States
New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Injectable extended-release buprenorphineSublingual buprenorphine-naloxone

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 14 Oct 2024
Primary completion: 4 Nov 2025
Completion: 14 Jan 2026
Last update posted: 29 Apr 2026
Registered enrollment: 140
Registry id: NCT06023459

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.