Single Ascending Dose Study of RBP-6000
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A multi-center, open-label, single ascending dose study to enroll opioid dependent
      treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and
      high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of
      RBP-6000 after receiving suboxone tablets for 7 days.
    

Detailed description: 
      All subjects will undergo screening period of up to 7 days. Eligible subjects in Cohorts 1-3
      will receive RBP-6000 doses on at the conclusion of screening. Subjects in Cohort 4 will
      receive sublingual (SL) Suboxone for 7 days prior to receiving an injection of RBP-6000.

      For all cohorts, subjects will be admitted to the clinic 2 days prior to beginning any
      dosing, and will remain in the clinic through Day 21. Blood collection for hematology,
      chemistry and serology analysis will be drawn at screening, and intermittently for safety
      assessments during the study period. Subjects in Cohorts 1-3 will have a PK sample collected
      pre-dose and serial PK collection post-dosing. Subjects in Cohort 4 will have daily PK
      collections while admitted during Suboxone dosing and serially after RBP-6000 administration.

      Subjects will return to the clinic for PK sample collection through Day 140 or until
      buprenorphine concentrations fall below 100 pg/mL. Subjects will return to the clinic for
      safety assessments through Day 150.

      Subjects experiencing signs and symptoms of withdrawal prior to RBP-6000 during the
      residential phase may receive non-opioid rescue medications. Subjects who experience signs
      and symptoms of withdrawal may receive hydromorphone beginning on Day 11 if necessary.
      Methadone dosing can begin, if clinically indicated, on Day 16 only for subjects who have not
      been administered hydromorphone. Subjects will not be allowed to use buprenorphine at any
      time during the study.

      Subjects will also receive psychosocial and behavioral counseling as specified by the PI. The
      End of Study visit will occur 1 week after Day 84 or 1 week after the monthly follow-up
      visits after Day 84, given a subject's buprenorphine plasma concentration has fallen below
      100 pg/mL. For subjects with plasma concentrations of buprenorphine above 100 pg/mL at Day
      140, Day 150 will be the End of Study visit.

      Subjects will not be enrolled into the next cohort until safety data for at least the first 6
      subjects has been reviewed.
    

Intervention name(s): RBP-6000; Suboxone
Intervention type(s): Drug; Drug
Intervention description(s): single dose of RBP-6000, preceded by a pharmacokinetic (PK) sample followed by serial PK samples post-dose. Additionally subjects to remain in the clinic through Day 21 for safety assessments; RBP-6000 injection after 7 days of SL Suboxone administration. Interventions as above with additional daily PK collections during Suboxone treatment prior to RBP-6000 administration
Other intervention name(s): atrigel buprenorphine
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment