Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) (NCT06023459) | Clinical Trial Compass
CompletedPhase 3
Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)
United States140 participantsStarted 2024-10-14
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparative effectiveness
Timeframe: Week 2 through Week 14 of the trial
2
Feasibility of study implementation
Timeframe: 14 weeks of the trial starting at randomization
3
Acceptability
Timeframe: 14 weeks of the trial starting at screening
. Be able to speak English sufficiently to understand the study procedures
Exclusion criteria
. 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
. 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