Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

Launched by YIH-ING HSER · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial, called RXR, is testing a new form of injectable medication called extended-release buprenorphine (XR-BUP) to help people with opioid use disorder (OUD) in rural areas. The study will compare XR-BUP, given once every four weeks, to a daily sublingual buprenorphine (SL-BUP) that is taken under the tongue. The goal is to see how effective and acceptable this new treatment is for individuals with moderate to severe OUD. The trial will involve 144 participants who are interested in receiving treatment and will follow them for 14 weeks to understand their experiences and outcomes.

To participate in this trial, individuals need to be at least 18 years old, have a diagnosis of moderate to severe OUD, and be willing to follow the study procedures. They should be in good health and able to communicate in English. However, people with certain serious mental health issues or medical conditions that make participation unsafe will not be eligible. Participants can expect to receive one of the two medications and will be monitored throughout the study. This trial is important as it aims to find effective treatment options for those struggling with opioid-related disorders, especially in rural settings where access to care may be limited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be ≥18 years of age
• • 2. Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD
• • 3. Be interested in receiving buprenorphine treatment for OUD
• • 4. Be willing to be randomized to either SL-BUP or XR-BUP
• • 5. Be willing to comply with all study procedures
• • 6. 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
• • 7. 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
• • 8. Be able to speak English sufficiently to understand the study procedures
• • 9. Be willing and able to provide written informed consent to participate in the study
• Exclusion Criteria:
• • 1. 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)
• • 2. Have suicidal or homicidal ideation or behavior that requires immediate attention
• • 3. Have a medical condition or serious medical illness that, in the opinion of the study Medical Clinician, would make study participation medically unsafe
• • 4. Have been in treatment with naltrexone within 28 days of consent
• • 5. Have been in methadone maintenance treatment within 28 days of consent
• • 6. Be taking medication or require any medication that, in the judgment of the study Medical Clinician, could interact adversely with study medication
• • 7. Have known allergy or sensitivity to SL-BUP or XR-BUP formulations or their components
• • 8. Be currently incarcerated or have pending legal action that could preclude participation in study activities
• • 9. Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
• • 10. 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
• • 11. Be currently pregnant or breastfeeding or planning on conception