Safety and Tolerability Study of Depot Buprenorphine in Treatment Seeking Subjects With Opioid Use Disorder
Status:
Completed
Trial end date:
2017-01-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Indivior Inc.
Treatments:
Buprenorphine Buprenorphine, Naloxone Drug Combination