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

This 24-month randomized controlled open-label pilot study will be conducted in approximately 6 clinics in rural settings. The study objectives are to describe the feasibility of implementing the study in rural settings, document the acceptability of the XR-BUP condition, and assess the comparative effectiveness of XR-BUP compared with SL-BUP. Participants will be randomized within each clinic to XR-BUP or SL-BUP in a ratio of 2:1 (overall approximately 96 in the XR-BUP condition, 48 in the SL-BUP condition). They will receive study medication for approximately 14 weeks following randomization, including an initial ~2-week period of induction/stabilization. The XR-BUP condition will use Brixadi®/CAM2038 injectable, extended-release buprenorphine. The measure for the main comparative effectiveness outcome is number of urine drug screen (UDS) results negative for opioids at scheduled assessments during Week 2 through Week 14 of the trial. Missing or positive UDS for any non-prescribed opioid is considered UDS positive.

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
• Be willing and able to provide written informed consent to participate in the study

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
• Have other situation that might prevent the participant from remaining in the area for the duration of the study (e.g., planned move)
• 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
• Be currently pregnant or breastfeeding or planning on conception