Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
NCT ID: NCT06023459
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
144 participants
INTERVENTIONAL
2024-10-14
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Injectable extended-release buprenorphine (XR-BUP)
Participants 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.
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 (SL-BUP)
Participants 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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institutes of Health (NIH)
NIH
The Emmes Company, LLC
INDUSTRY
University of California, Los Angeles
OTHER
RAND
OTHER
Cornell University
OTHER
Oregon Health and Science University
OTHER
University of Illinois at Chicago
OTHER
University of Washington
OTHER
West Virginia University
OTHER
Yih-Ing Hser
OTHER
Responsible Party
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Yih-Ing Hser
Distinguished Research Professor, Department of Psychiatry and Behavioral Sciences, Geffen School of Medicine
Principal Investigators
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Yih-Ing Hser, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Larissa Mooney, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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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
Countries
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Other Identifiers
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CTN-0102-XR
Identifier Type: -
Identifier Source: org_study_id