Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users

Exclusion Criteria

• •1. Has current diagnosis, other than OUD, requiring chronic opioid treatment.
• •2. Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis or alcohol use disorders.
• •3. Meets DSM-5 criteria for severe alcohol use disorder.
• •4. Has had significant traumatic injury or major surgical procedure (as defined by the Investigator) within 30 days prior to the first dose of RBP-6000 or still recovering from prior such injury or surgery.
• •5. Has congenital long QT syndrome, history of prolonged QT in the 3 months prior to Screening, or history of medications or other factors that are at risk for Torsades de Pointes.
• •6. Has abdominal area unsuitable for subcutaneous injections (e.g., nodules, scarring, lesions, excessive pigment).
• •7. Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.
• •8. Has uncontrolled intercurrent illness including, but not limited to, a medical or psychiatric illness/social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent.
• •9. Has any other active medical condition, organ disease or concurrent medication or treatment that may either compromise participant safety or interfere with study endpoints.
• •10. Has total bilirubin ≥ 1.5 × upper limit of normal (ULN) (with direct bilirubin \> 1.3 mg/dL), alanine aminotransferase (ALT) ≥ 3 × ULN, aspartate aminotransferase (AST) ≥ 3 × ULN, serum creatinine \> 2 × ULN, or international normalized ratio (INR) \> 1.5 × ULN at Screening.
• •11. Has known allergy or hypersensitivity to buprenorphine or any component of the ATRIGEL Delivery System.
• •12. Is undergoing concurrent or has had prior treatment with any long-acting form of buprenorphine-containing product in the past 2 years, or if \> 2 years has a positive UDS for buprenorphine at screening; treatment with oral buprenorphine, oral naltrexone or methadone products within 14 days prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.
• •13. Is undergoing concurrent treatment with another investigational agent or enrollment in another clinical study (except for an observational study) or treatment with another investigational agent within 30 days prior to Screening.
• •14. Is undergoing concurrent treatment with medications contraindicated for use with buprenorphine as per local prescribing information.
• •15. Has any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures.
• •16. Is under court order requiring treatment for OUD.
• •17. Is a member of site staff and/or has a financial interest in Indivior, or is an immediate family member of either the site staff and/or Indivior employee, directly involved in the study.