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Opioid Agonist
Extended-release vs Sublingual Buprenorphine for Opioid Use Disorder (RXR Trial)
Phase 3
Waitlist Available
Led By Yih-Ing Hser, PhD
Research Sponsored by Yih-Ing Hser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥18 years of age
Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
RXR Trial Summary
This trial will explore how well an extended-release injectable medication helps people with opioid use disorder in rural areas. It will compare it to a standard medication. Results will include patient outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include nausea, constipation, headache, sweating, insomnia, pain at the injection site for XR-BUP; similar effects plus mouth numbness or irritation may occur with SL-BUP.
RXR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a moderate to severe opioid use disorder or am on buprenorphine.
RXR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparative effectiveness
Secondary outcome measures
Acceptability of XR-BUP
Feasibility of study implementation
RXR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Injectable extended-release buprenorphine (XR-BUP)Experimental Treatment1 Intervention
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.
Group II: Sublingual buprenorphine-naloxone (SL-BUP)Active Control1 Intervention
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).
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Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,347 Total Patients Enrolled
University of California, Los AngelesOTHER
1,529 Previous Clinical Trials
10,277,658 Total Patients Enrolled
University of Illinois at ChicagoOTHER
607 Previous Clinical Trials
1,559,211 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned the utilization of injectable extended-release buprenorphine (XR-BUP)?
"Data collected from multiple clinical trials and studies has given our team at Power enough evidence to rate Injectable extended-release buprenorphine (XR-BUP) as a 3 on the safety scale."
Answered by AI
Are there still vacancies available for potential participants in this research?
"The details on clinicaltrials.gov demonstrate that this medical trial is not currently in need of participants, having been first published on January 1st 2024 and last updated on August 28th 2023. Nevertheless, there are 531 other trials presently searching for volunteers."
Answered by AI
How many health care facilities are participating in this experiment?
"Gibson Area Hospital and Health Services - Gibson Recovery Optimizing Wellness in Gibson City, Illinois; Oregon Health & Science University Primary Care Clinic, Scappoose in Scappoose, Oregon; Harbor Regional Health - HarborCrest Behavioral Health in Aberdeen, Washington; as well as a further six sites are all participating locations for this clinical trial."
Answered by AI
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