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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately
      300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901
      (RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not
      participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and
      completion of screening procedures, all subjects will receive SUBOXONE sublingual film,
      titrated to response.

      After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for
      enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose,
      followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of
      the investigator.

      Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive
      monthly injections for up to 6 months. Subjects who did not participate in study
      RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.

      At all injection visits continuous electrocardiogram recordings and pulse oximetry will be
      collected prior to injection and at least 4 hours after injection. Subjects will return to
      the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event
      and injection site assessments.
    

Intervention name(s): SUBOXONE sublingual film; RBP-6000
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): SUBOXONE; buprenorphine; Atrigel buprenorphine
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment