Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate
to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of
Mental Disorders, 5th Edition (DSM-5) to evaluate the effectiveness of RBP-6000 to block the
effects of exogenous opioids.
The primary objective of this study was to demonstrate that the "Drug Liking" visual analog
scale (VAS) measured after challenge with 6 mg (Dose 1) and 18 mg (Dose 2) hydromorphone was
noninferior to the "Drug Liking" visual analog scale (VAS) measured after challenge with
placebo at Weeks 1-4 post first injection of subcutaneous buprenorphine 300 mg (RBP-6000).
Phase:
Phase 2
Details
Lead Sponsor:
Indivior Inc.
Treatments:
Analgesics, Opioid Buprenorphine Buprenorphine, Naloxone Drug Combination Hydromorphone Naloxone