RECRUITING

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

Description

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.

Conditions

Opioid-Related DisordersSubstance-Related DisordersNarcotic-Related Disorders
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Related Conditions:

Opioid-Related DisordersSubstance-Related DisordersNarcotic-Related Disorders

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Opioid-Related Disorders
Intervention / Treatment

-

Contacts and Locations

El Dorado

AppleGate Recovery El Dorado, El Dorado, Arkansas, United States, 71730

Garberville

Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital, Garberville, California, United States, 95542

Gibson City

Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness, Gibson City, Illinois, United States, 60936

Belfast

Penobscot Community Health Care Inc. - Seaport Community Health Center, Belfast, Maine, United States, 04915

Scappoose

Oregon Health & Science University Primary Care Clinic, Scappoose, Scappoose, Oregon, United States, 97056

Colville

Providence Northeast Washington Medical Group, Colville, Washington, United States, 99114

New Martinsville

New Beginnings Recovery Clinic & Behavioral Health Center, New Martinsville, West Virginia, United States, 26155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be ≥18 years of age
  • 2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
  • 3. Be interested in receiving buprenorphine treatment for OUD
  • 4. Be willing to be randomized to either SL-BUP or XR-BUP
  • 5. Be willing to comply with all study procedures
  • 6. 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
  • 7. 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
  • 8. Be able to speak English sufficiently to understand the study procedures
  • 9. Be willing and able to provide written informed consent to participate in the study
  • 1. 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)
  • 2. Have suicidal or homicidal ideation or behavior that requires immediate attention
  • 3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
  • 4. Have been in treatment with naltrexone within 28 days of consent
  • 5. Have been in methadone maintenance treatment within 28 days of consent
  • 6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
  • 7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
  • 8. Be currently incarcerated or have pending legal action that could preclude participation in study activities
  • 9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
  • 10. 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
  • 11. Be currently pregnant or breastfeeding or planning on conception

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yih-Ing Hser,

Yih-Ing Hser, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Larissa Mooney, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

2026-02-28