Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01582347 | Transfer of Subjects From Subutex/Suboxone to RBP-6300 | PHASE2 | COMPLETED | 143 | — | — | Mar 1, 2012 | Nov 1, 2012 | Jan 20, 2017 | 15 | Austria, Czechia +2 |
To demonstrate that RBP-6300 is not inferior to Subutex/Suboxone as assessed by the peak change from baseline in the pre-dose COWS score during the double-blind transfer phase
| Arm | Type | Description |
|---|---|---|
| RBP-6300 | EXPERIMENTAL | During the Double-Blind Transfer Period (Days 1-7), participants take RBP-6300 at a level (either 10, 20 or 30 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for Subutex®/Suboxone®. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. |
| Subutex®/Suboxone® | ACTIVE_COMPARATOR | During the Double-Blind Transfer Period (Days 1-7), participants take Subutex®/Suboxone® at a level (either 8, 16 or 240 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for RBP-6000. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000. |
| Name | Type | Description |
|---|---|---|
| RBP-6300 | DRUG | Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7). Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate. |
| Subutex®/Suboxone® | DRUG | Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods. Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods. Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone. |
| Placebo for RBP-6300 | DRUG | Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods. Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period. |
| Placebo for Subutex®/Suboxone® | DRUG | Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period. |
Inclusion Criteria: * Be Male or non-pregnant, non-lactating females * Be at least 18 years of age * Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening * Be on stable dose of 8, 16, or...