Clinical Research Directory
Browse clinical research sites, groups, and studies.
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
Sponsor: Yih-Ing Hser
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
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.
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