Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
RXR
Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
2 other identifiers
interventional
144
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2024
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedStudy Start
First participant enrolled
October 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedDecember 31, 2025
December 1, 2025
1 year
August 8, 2023
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Comparative effectiveness
Number of urine drug screen (UDS) results negative for opioids
Week 2 through Week 14 of the trial
Feasibility of study implementation
The extent to which XR-BUP can be implemented in rural clinic settings, including recruitment, consent, study completion.
14 weeks of the trial starting at randomization
Acceptability
Acceptability of XR-BUP by those implementing or receiving XR-BUP if it is agreeable or satisfaction, percent receiving the first monthly injection, percent receiving at least the first two monthly injection
14 weeks of the trial starting at screening
Study Arms (2)
Injectable extended-release buprenorphine (XR-BUP)
EXPERIMENTALParticipants will be randomly assigned to XR-BUP, with approximately 96 in the XR-BUP condition. The XR-BUP condition will use Brixadi/CAM2038 injectable, extended-release buprenorphine (Braeburn Pharmaceuticals, Inc.). After titrating to a stable dosage in approximately two weeks using weekly injection dosages as clinically indicated to relieve cravings and withdrawal symptoms, the target monthly dosage (128mg) of XR-BUP will be administered by injection at approximately Day 14 and approximately four weeks later in Week 6, with a third injection in Week 10. Dosage adjustments will be made as indicated for tolerability.
Sublingual buprenorphine-naloxone (SL-BUP)
ACTIVE COMPARATORParticipants will be randomly assigned to SL-BUP with approximately 48 in the SL-BUP condition. The SL-BUP condition will use sublingual buprenorphine-naloxone, with a target maintenance daily dose range of 16-24mg as recommended for clinical practice. Titration to maintenance dosage will be attempted within the first two weeks of the SL-BUP condition. During the initial stabilization weeks, SL-BUP will be flexibly dosed as clinically indicated to relieve cravings and withdrawal symptoms, after which dosage adjustments will be based on clinical decisions by the site clinicians. The maintenance dosage of SL-BUP will be dispensed on a schedule similar to the XR-BUP injections (i.e., at approximately Day 14, Week 6, and Week 10).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Be ≥18 years of age
- Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
- Be interested in receiving buprenorphine treatment for OUD
- Be willing to be randomized to either SL-BUP or XR-BUP
- Be willing to comply with all study procedures
- Be in good general health, as determined by the study Medical Clinician based on medical/psychiatric histories and physical exam, to permit treatment in an outpatient setting
- If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study intervention and agree to study-administered pregnancy testing during their participation in the study
- Be able to speak English sufficiently to understand the study procedures
- Be willing and able to provide written informed consent to participate in the study
You may not qualify if:
- Have evidence of a serious psychiatric disorder as assessed by the study Medical Clinician that would make participation difficult or unsafe (e.g., active psychosis, severe depression, or mania)
- Have suicidal or homicidal ideation or behavior that requires immediate attention
- Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
- Have been in treatment with naltrexone within 28 days of consent
- Have been in methadone maintenance treatment within 28 days of consent
- Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
- Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
- Be currently incarcerated or have pending legal action that could preclude participation in study activities
- Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
- Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study Medical Clinician, that would require a different level of care and preclude safe participation in the study
- Be currently pregnant or breastfeeding or planning on conception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yih-Ing Hserlead
- National Institute on Drug Abuse (NIDA)collaborator
- National Institutes of Health (NIH)collaborator
- The Emmes Company, LLCcollaborator
- University of California, Los Angelescollaborator
- RANDcollaborator
- Cornell Universitycollaborator
- Oregon Health and Science Universitycollaborator
- University of Illinois at Chicagocollaborator
- University of Washingtoncollaborator
- West Virginia Universitycollaborator
Study Sites (7)
AppleGate Recovery El Dorado
El Dorado, Arkansas, 71730, United States
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, 95542, United States
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, 60936, United States
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, 04915, United States
Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, 97056, United States
Providence Northeast Washington Medical Group
Colville, Washington, 99114, United States
New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, 26155, United States
Related Publications (1)
Mooney LJ, Saxon AJ, Black M, Ober AJ, Lewis M, Walker R, McCormack J, Scheele C, Hser YI. Randomized controlled pilot trial of extended-release buprenorphine vs. sublingual buprenorphine-naloxone in rural settings (RXR): Study rationale and design. Contemp Clin Trials. 2026 Mar 16:108288. doi: 10.1016/j.cct.2026.108288. Online ahead of print.
PMID: 41850520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yih-Ing Hser, PhD
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Larissa Mooney, MD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine
Study Record Dates
First Submitted
August 8, 2023
First Posted
September 5, 2023
Study Start
October 14, 2024
Primary Completion
October 31, 2025
Study Completion
February 28, 2026
Last Updated
December 31, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the main outcome(s) paper(s) have been published or 18 months after data lock, whichever comes first.
- Access Criteria
- For more details on data sharing please visit https://datashare.nida.nih.gov
This study will comply with the NIH Data Sharing Policy and Implementation Guidance and the HEAL Public Access and Data Sharing Policy. Primary data for this study will be available to the public in the NIDA Data Share repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.The main outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).