Transfer of Subjects From Subutex/Suboxone to RBP-6300
- Conditions
- Opioid Related Disorder
- Interventions
- Drug: RBP-6300Drug: Subutex®/Suboxone®Drug: Placebo for RBP-6300Drug: Placebo for Subutex®/Suboxone®
- Registration Number
- NCT01582347
- Lead Sponsor
- Indivior Inc.
- Brief Summary
This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone
- Detailed Description
During the open-label Run-In Period (study days -7 to -1), participants receive Subutex®/Suboxone® at one of three dose levels, depending on the dose level for that subject on entry to the study: 8 mg/day, 16 mg/day, or 24 mg/day.
During the 7-day, active drug-controlled, double-blind Transfer Period (study days 1-7), participants are randomized to either Subutex®/Suboxone® or RBP-6300 active drug at dosing levels equivalent to the level during the Run-In Period plus placebo matching the other drug.
This is followed by a 3-day single-blind Subutex®/Suboxone® Transition Period in which participants receive the same dose given during the Run-In Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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 24mg/day for about 30 days prior to screening
- Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study
- Have participated in an experimental drug or device study within the last 60 days
- If female, be breast feeding or lactating
- Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study
- Have a clinically significant abnormal finding (in the opinion of the investigator)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RBP-6300 RBP-6300 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. RBP-6300 Subutex®/Suboxone® 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. RBP-6300 Placebo for RBP-6300 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. RBP-6300 Placebo for Subutex®/Suboxone® 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® Subutex®/Suboxone® 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. Subutex®/Suboxone® Placebo for RBP-6300 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.
- Primary Outcome Measures
Name Time Method Treatment 7 days 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
- Secondary Outcome Measures
Name Time Method Assess the overall clinical response to RBP-6300 one year One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events
Trial Locations
- Locations (15)
Dr. Lindenbauer
🇦🇹Linz, Austria
Dr. Tietje
🇩🇪Bremen, Germany
Dr. Vehak
🇨🇿Prague, Czech Republic
Prof. Scherbaum
🇩🇪Essen, Germany
Dr. Weber
🇩🇪Kassel, Germany
PD. Dr. Pogarell
🇩🇪Munich, Germany
Dr. Rechenmacher
🇩🇪Oldenburg, Germany
Dr. Kilaidakis
🇸🇪Orebro, Sweden
Dr. Boniakowski
🇩🇪Regensburg, Germany
Dr. Georgieva
🇸🇪Stockholm, Sweden
Dr. Issler
🇩🇪Stuttgart, Germany
Prof. Wolzt
🇦🇹Wien, Austria
Dr. Stankova
🇨🇿Usti nad Labem, Czech Republic
Prof. Dr. Wurst
🇦🇹Salzburg, Austria
Prof. Dr. Fleischhacker
🇦🇹Austria, Austria