Open-Label Treatment Extension Study
Condition: Opioid Use Disorder; Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: RBP-6000
Intervention description: Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who
      complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not
      been identified or arranged.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written consent to participate in this study.

          2. Completed the End of Study Visit for the RB-US-13-0003 study (NCT02510014).

          3. Be considered eligible in the medical judgment of the Investigator.

          4. Females: Women of childbearing potential (defined as all women who are not surgically
             sterile or postmenopausal for at least 1 year prior to informed consent form (ICF))
             must have a negative pregnancy test prior to enrollment and must agree to use a
             medically acceptable means of contraception from screening through at least 6 months
             after the last dose of investigational medicinal product (IMP).

             Males: Subjects with female partners of child-bearing potential must agree to use
             medically acceptable contraception after signing the ICF through at least 6 months
             after the last dose of IMP. Male subjects must also agree not to donate sperm during
             the study and for 6 months after receiving the last dose of IMP.

          5. Subjects must agree not to take any buprenorphine products other than those
             administered during the current study throughout participation in the study.

          6. Subjects must be willing to adhere to study procedures.

        Exclusion Criteria:

          1. Subject compliance issues during participation in the RB-US-13-0003 study which, in
             the opinion of the Investigator, could potentially compromise subject safety.

          2. Women of childbearing potential who have a positive pregnancy test at RB-US-13-0003 at
             the end-of-study (EOS) visit, who are pregnant or breastfeeding, seeking pregnancy, or
             failing to use adequate contraceptive methods during the study.

          3. History of suicidal ideation within 28 days prior to signing the ICF as evidenced by
             answering "yes' to questions 4 or 5 on the suicidal ideation portion of the
             Columbia-Suicide Severity Rating Scale (C-SSRS) "since last visit" assessment
             (completed in the EOS Visit for Study RB-US-13-0003), screening/baseline" assessment
             for the current study), or history of a suicide attempt (per the C-SSRS) in the 6
             months prior to signing the ICF.

          4. Taking any cytochrome P450 3A4 and 2C8 inducers and inhibitors, self-reported
             additional buprenorphine, or over the counter (OTC) and/or herbal supplements with the
             potential to prolong QTc within 28 days of Day 1 unless prior written approval was
             obtained from the Medical Monitor.