Open-Label Treatment Extension Study
Condition: Opioid Use Disorder; Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This is a multi-center, open-label, RBP-6000 treatment extension study in which subjects who
      have completed the End of Study (EOS) procedures for study RB-US-13-0003 are eligible. EOS
      assessments completed at the RB-US-13-0003 EOS visit serve as part of the screening visit for
      this study. In addition, subjects were requested to complete a Columbia Suicide Severity
      Rating Scale (C-SSRS) baseline/screening survey and a medical history and height was
      obtained.

      The informed consent may be shared with subjects up to 2 months prior to the RB-US-13-0003
      EOS visit, however should not be signed until all assessments for the EOS visit have been
      completed.

      On Day 1, eligible subjects receive a subcutaneous (SC) injection of RBP-6000 at a low or
      high dose based on the medical judgment of the investigator. After the injection, vital signs
      and the injection site were assessed. Prior to departing the site, subjects were also
      assessed for adverse events (AEs) and use of concomitant medications (ConMeds).

      Subjects return to the site for monthly injection visits every 28 days (-2 / +7 days) for a
      total of up to 6 injections (participants were not required to complete all 6 injections). At
      each subsequent visit (Injections 2 through 6) the following procedures / assessments were
      performed : urine pregnancy test performed for all female subjects who are of childbearing
      potential before each injection; previous injection site assessed for potential reaction and
      evidence of attempts to remove the depot; vital signs collected pre and post each injection;
      RBP-6000 injection, urine drug screen (UDS); C-SSRS since last visit assessment, counseling
      (manual-guided behavioral therapy); use of ConMeds; local injection site grading, subject
      self-assessment of injection site pain (Injection Site Pain Visual Analog Scale [VAS]),
      assessment for adverse events (AEs).

      Laboratory tests (hematology, chemistry and urinalysis) may be requested by the Investigator
      on an ad-hoc basis in order to assess for AEs.

      A subject's alternative treatment options were assessed at least two months before EOS at
      each visit.

      At EOS or early termination (ET), the following assessments were performed: urine pregnancy
      test performed for all female subjects who are of childbearing potential; vital signs;
      previous injection site assessed for potential reaction and evidence of attempts to remove
      the depot; UDS; C-SSRS since last visit assessment, counseling (manual-guided behavioral
      therapy); use of ConMeds; assessment for AEs; a brief physical exam; height and body weight
      were measured and a subject's body mass index (BMI) and waist-to-hip ratio calculated;
      laboratory tests (hematology, chemistry, urinalysis).

      Subjects were to be contacted by telephone approximately 4 weeks after EOS/ET for a safety
      follow-up assessment of AEs and use of ConMeds.
    

Intervention name(s): RBP-6000
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): atrigel buprenorphine; extended-release buprenorphine
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment