Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
Condition: Opioid Use Disorder; Opioid-related Disorders
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: SUBOXONE sublingual film; RBP-6000
Intervention description: SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.; Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 775.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A multi-center, open-label, long-term safety study in which approximately 600 subjects
      diagnosed with opioid use disorder will be enrolled. Following a screening period, all
      subjects will receive run in SUBOXONE sublingual film followed by an initial injection of
      open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted
      to low dose (100 mg), and back to high dose, based on the medical judgment of the
      Investigator. Subjects will participate in the study for either 6 or 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

        De novo subjects:

          -  Seeking treatment for opioid use disorder (OUD) and for the previous 3 months meet the
             Diagnostic and Statistical Manual 5 (DSM-5) criteria for moderate or severe OUD

          -  Appropriate candidate for opioid partial-agonist treatment

          -  BMI between 18 and 35, inclusive

        Roll-over subjects:

          -  Completed RB-US-13-0001

        Exclusion Criteria:

        De novo subjects:

          -  Current diagnosis, other than OUD, requiring chronic opioid treatment

          -  Current substance use disorder with regard to substances other than opioids, cocaine,
             cannabis, tobacco or alcohol

          -  Received medication-assisted treatment for OUD in the 90 days prior to informed
             consent

          -  Use (within past 30 days prior to informed consent) or positive urine drug screen
             (UDS) at screening for barbiturates, benzodiazepines,methadone or buprenorphine

          -  Treatment for OUD required by court order

          -  History of recent suicidal ideation or attempt

        Roll over subjects:

          -  Experienced major protocol deviations or adverse events in RB-US-13-0001 which could
             potentially compromise subject safety

          -  Discontinued early from study RB-US-13-0001