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 range18 Years
SexALL
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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
✓. 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)
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
✕. 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