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

Completed · Phase 3

Conditions studied: Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders

In brief

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.

Key facts

Study ID

NCT06023459

Run by

Yih-Ing Hser

People needed

140

Starts

2024-10-14

Expected to finish

2026-01-14

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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