Extended-release vs Sublingual Buprenorphine for Opioid Use Disorder
(RXR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two forms of buprenorphine, a medication for opioid use disorder (OUD), to determine which is more effective in rural areas. One group receives an extended-release injection every four weeks, while the other takes a daily under-the-tongue tablet. The researchers aim to compare these treatments in terms of effectiveness, convenience, and patient satisfaction. Individuals with moderate to severe OUD who are already using or interested in buprenorphine treatment and willing to try either form might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to significant research that could lead to new treatment options.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been on naltrexone or methadone within 28 days before joining. Also, if any of your medications could interact badly with the study drugs, you might need to stop them.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both extended-release buprenorphine and sublingual buprenorphine are generally safe for treating opioid use disorder. Studies have found that extended-release buprenorphine (XR-BUP) is usually well-tolerated, with a safety profile similar to sublingual buprenorphine-naloxone, a pill that dissolves under the tongue. Most side effects are mild, such as headaches or nausea.
Sublingual buprenorphine is already a common and effective treatment for opioid use disorder and has been used safely by many people. When combined with naloxone, sometimes called SL-BUP, it helps reduce misuse, meaning using the drug in a way it wasn't prescribed.
Both treatments have been extensively studied and have shown a good track record for safety. Evidence supports that they are generally well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments for opioid use disorder being tested because they offer new ways to manage this challenging condition. Unlike traditional sublingual buprenorphine, which requires daily dosing, extended-release buprenorphine (XR-BUP) is administered via injection and lasts for weeks, potentially improving adherence by reducing the burden of daily medication. This could mean fewer missed doses and more consistent management of cravings and withdrawal symptoms. Additionally, having an injectable option might provide more flexibility and convenience for patients who struggle with the routine of daily medication. These features could make a big difference in the lives of those dealing with opioid dependency.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
This trial will compare extended-release buprenorphine (XR-BUP) with sublingual buprenorphine (SL-BUP) for treating opioid use disorder (OUD). Research has shown that XR-BUP effectively treats OUD. In one study, patients using XR-BUP reported greater satisfaction with their treatment over time compared to those using SL-BUP. Another study found XR-BUP effective for patients at high risk of overdose. SL-BUP has also proven effective for OUD, with patients adhering to their treatment and experiencing a low chance of relapse. Both treatments help by reducing cravings and withdrawal symptoms, making it easier for patients to manage OUD.14567
Who Is on the Research Team?
Yih-Ing Hser, PhD
Principal Investigator
University of California, Los Angeles
Larissa Mooney, MD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for adults over 18 with moderate to severe opioid use disorder (OUD) who live in rural areas. They must speak English, agree to birth control if applicable, and be willing to take either sublingual or injectable buprenorphine as treatment. People can't join if they've recently used methadone, have certain medical or psychiatric conditions, are pregnant/breastfeeding, or have legal issues that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction/Stabilization
Initial period of induction and stabilization with study medication
Treatment
Participants receive study medication for opioid use disorder
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Extended-release Buprenorphine
- Sublingual Buprenorphine
Trial Overview
The study compares two forms of buprenorphine: a monthly injectable extended-release version (XR-BUP) and a daily sublingual tablet (SL-BUP). Participants will be randomly assigned to one of these treatments for 14 weeks and monitored through assessments and interviews to determine which is more effective in rural settings.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yih-Ing Hser
Lead Sponsor
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
University of California, Los Angeles
Collaborator
University of Illinois at Chicago
Collaborator
RAND
Collaborator
Cornell University
Collaborator
West Virginia University
Collaborator
Oregon Health and Science University
Collaborator
University of Washington
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Extended-release Buprenorphine Compared to Sublingual ...
The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during ...
Extended-release injectable buprenorphine for the ...
This prospective clinical cohort study found that among 25 patients with OUD at high risk of overdose who started XR-BUP in were followed in a low-barrier ...
Transition to Extended-release Buprenorphine Injectable ...
Of patients, 4% experienced withdrawal symptoms requiring additional opioid support. All Bup-LA-B studies reported transitions within 24 hours.
Buprenorphine extended-release injection (Brixadi®) in the ...
In the DEBUT trial, patients who received subcutaneous buprenorphine ER reported higher and more sustained treatment satisfaction than those who ...
Extended-Release Buprenorphine for Persons With Opioid ...
Treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 quality-adjusted life-years per person at higher cost.
Extended-Release 7-Day Injectable Buprenorphine for ...
Meaning Results of this study suggest that 7-day extended-release buprenorphine may be feasible in patients with opioid use disorder presenting ...
Initiation and Dosing of Extended-Release Buprenorphine
Individuals with Opioid Use Disorder (OUD) who use fentanyl are at high risk of mortality due to opioid-related overdose.
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