At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
RBP-6000drug
Likely dose
RBP-6000 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Depot Buprenorphine (RBP-6000) Treatment Extension Study in Subjects With Opioid Use Disorder
In Brief
A Phase 3 clinical trial evaluating RBP-6000 for Opioid Use Disorder and Opioid-related Disorders. Completed, enrolled 208 participants across 29 sites.
Detailed Summary
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder, Opioid-related Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedSep 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedSep 12, 2016
Enrollment StartAug 17, 2016
Primary CompletionAug 23, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.8 years ago
Interventions
RBP-6000drug
Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.