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ACTIVE NOT RECRUITING
NCT06023459
PHASE3

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

Sponsor: Yih-Ing Hser

View on ClinicalTrials.gov

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.

Official title: Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-10-14

Completion Date

2026-02-28

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DRUG

Injectable extended-release buprenorphine

Participants randomized to the XR-BUP condition will receive XR-BUP study medication for approximately 14 weeks following randomization, including an initial \~2-week period of induction/stabilization.

DRUG

Sublingual buprenorphine-naloxone

Participants randomized to the SL-BUP condition will receive SL-BUP study medication for approximately 14 weeks following randomization, including an initial \~2-week period of induction/stabilization.

Locations (7)

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