Opioid-Related DisordersPhase 3RXRNCT06023459
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
A Phase 3 study testing Injectable extended-release buprenorphine and Sublingual buprenorphine-naloxone in people with Opioid-Related Disorders and Substance-Related Disorders, run by Yih-Ing Hser at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders
- What is being tested?
- Injectable extended-release buprenorphine and Sublingual buprenorphine-naloxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Oct 2024to 14 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Penobscot Community Health Care Inc. - Seaport Community Health Center
Belfast, Maine, 04915
Providence Northeast Washington Medical Group
Colville, Washington, 99114
AppleGate Recovery El Dorado
El Dorado, Arkansas, 71730
Southern Humboldt Community Healthcare District - Jerold Phelps Community Hospital
Garberville, California, 95542
Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness
Gibson City, Illinois, 60936
New Beginnings Recovery Clinic & Behavioral Health Center
New Martinsville, West Virginia, 26155
Oregon Health & Science University Primary Care Clinic, Scappoose
Scappoose, Oregon, 97056
About this study
Official title: Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
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.
Read the detailed description
This 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. The study objectives are to describe the feasibility of implementing the study in rural settings, document the acceptability of the XR-BUP condition, and assess the comparative effectiveness of XR-BUP compared with SL-BUP. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization. The XR-BUP condition will use Brixadi®/CAM2038 injectable, extended-release buprenorphine. The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during Week 2 through Week 14 of the trial. Missing or positive UDS for any non-prescribed opioid is considered UDS positive.
- Being tested
- Injectable extended-release buprenorphine, Sublingual buprenorphine-naloxone
- Keywords
- Opioid Use Disorder, Opioid Medication Assisted Treatment, Buprenorphine, Comparative Effectiveness Research
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable extended-release buprenorphineDrug
Also called XR-BUP (Brixadi)
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-naloxoneDrug
Also called SL-BUP
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.
| Study group | Role | What they receive |
|---|---|---|
| Injectable extended-release buprenorphine (XR-BUP) | Experimental | 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. Receives: Drug: Injectable extended-release buprenorphine |
| Sublingual buprenorphine-naloxone (SL-BUP) | Active comparator | 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). Receives: Drug: Sublingual buprenorphine-naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative effectiveness
Number of urine drug screen (UDS) results negative for opioids
Measured: 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.
Measured: 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
Measured: 14 weeks of the trial starting at screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start14 Oct 2024
- Primary completion4 Nov 2025
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial \~2-week period of induction/stabilization.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yih-Ing Hser
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), The Emmes Company, LLC, University of California, Los Angeles, RAND, Cornell University, Oregon Health and Science University, University of Illinois Chicago, University of Washington, West Virginia University
- Responsible party
- Sponsor-investigator, Yih-Ing Hser, University of California, Los Angeles
- Investigators
- Yih-Ing Hser, PhD, Principal investigator, University of California, Los AngelesLarissa Mooney, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023459
- Sponsor's protocol ID
- CTN-0102-XR
- Other IDs
- UG1DA049435
- Acronym
- RXR
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Publications
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 May;164:108288. doi: 10.1016/j.cct.2026.108288. Epub 2026 Mar 16.
PubMed 41850520
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial of Extended-released Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings
- ClinicalTrials.gov ID
- NCT06023459
- Acronym / sponsor ID
- RXR / CTN-0102-XR
- Keywords
- Opioid Use Disorder, Opioid Medication Assisted Treatment, Buprenorphine, Comparative Effectiveness Research
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Yih-Ing HserUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), The Emmes Company, LLC, University of California, Los Angeles, RAND, Cornell University, Oregon Health and Science University, University of Illinois Chicago, University of Washington, West Virginia University
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. The study objectives are to describe the feasibility of implementing the study in rural settings, document the acceptability of the XR-BUP condition, and assess the comparative effectiveness of XR-BUP compared with SL-BUP. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization. The XR-BUP condition will use Brixadi®/CAM2038 injectable, extended-release buprenorphine. The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during Week 2 through Week 14 of the trial. Missing or positive UDS for any non-prescribed opioid is considered UDS positive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization.
| Arm | Type | Receives |
|---|---|---|
| Injectable extended-release buprenorphine (XR-BUP) | Experimental | Drug: Injectable extended-release buprenorphineParticipants 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 comparator | Drug: Sublingual buprenorphine-naloxoneParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injectable extended-release buprenorphineAlso: XR-BUP (Brixadi)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. | Drug | Injectable extended-release buprenorphine (XR-BUP) |
| Sublingual buprenorphine-naloxoneAlso: SL-BUPParticipants 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. | Drug | Sublingual buprenorphine-naloxone (SL-BUP) |
Primary outcome
Comparative effectiveness
Time frame: Week 2 through Week 14 of the trial
Number of urine drug screen (UDS) results negative for opioids
Feasibility of study implementation
Time frame: 14 weeks of the trial starting at randomization
The extent to which XR-BUP can be implemented in rural clinic settings, including recruitment, consent, study completion.
Acceptability
Time frame: 14 weeks of the trial starting at screening
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41850520Mooney 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 May;164:108288. doi: 10.1016/j.cct.2026.108288. Epub 2026 Mar 16.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yih-Ing Hser, PhD principal investigator
University of California, Los Angeles
Larissa Mooney, MD principal investigator
University of California, Los Angeles
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injectable extended-release buprenorphine and Sublingual buprenorphine-naloxone in people with Opioid-Related Disorders and Substance-Related Disorders, run by Yih-Ing Hser at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative effectiveness (time frame: Week 2 through Week 14 of the trial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.