drugset / Trial / NCT02559973

Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

NCT02559973

Phase 1 Completed 47 enrolled Indivior Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.

Timeline

Start
2015-09
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject RBP-6000 Unknown 300 mg Subcutaneous
Background Buprenorphine Other / unclassified Other