Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Public ClinicalTrials.gov record NCT06023459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06023459
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 140 participants
Conditions and interventions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2024
- Primary completion
- Nov 3, 2025
- Completion
- Jan 13, 2026
- Last update posted
- Apr 28, 2026
2024 – 2026
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AppleGate Recovery El Dorado | El Dorado | Arkansas | 71730 | — |
| Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital | Garberville | California | 95542 | — |
| Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness | Gibson City | Illinois | 60936 | — |
| Penobscot Community Health Care Inc. - Seaport Community Health Center | Belfast | Maine | 04915 | — |
| Oregon Health & Science University Primary Care Clinic, Scappoose | Scappoose | Oregon | 97056 | — |
| Providence Northeast Washington Medical Group | Colville | Washington | 99114 | — |
| New Beginnings Recovery Clinic & Behavioral Health Center | New Martinsville | West Virginia | 26155 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06023459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06023459 live on ClinicalTrials.gov.