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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the overall clinical response to RBP-6300 | One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Scherbaum, Prof. Dr. | Medical University, Duisburg-Essen, Germany | Principal Investigator |
| Michael Wolzt, Prof. Dr. | Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien | Principal Investigator |
| Wolfgang Fleischhacker, Prof. Dr. | Medical University Innsbruck | Principal Investigator |
| Vratislav Rehak, Dr. | Remedis s.r.o., Prague | Principal Investigator |
| Zdenka Stankova, Dr. | Masaryk Hospital Usti nad Labem | Principal Investigator |
| Oliver Pogarell, PD. Dr. | Medical University, Munich | Principal Investigator |
| Bernd Weber, Dr. | Praxis Dr. Bernd Weber am Koenigsplatz Schwerpunkprax is fur Suchtmedizin, Kassel | Principal Investigator |
| Edith Issler, Dr. | Infectomed GbR Zentrum fuer medizinische Studien, Stuttgart | Principal Investigator |
| Wieland Tietje, Dr. | Drs. Tieje, Heer & Koc, Bremen |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Fleischhacker | Austria | 6020 | Austria | |||
| Dr. Lindenbauer |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
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| 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. |
|
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| Principal Investigator |
| Eduard Boniakowski, Dr. | Psychosoziale Begleitung - Praxis Boniakowski, Regensburg | Principal Investigator |
| Charlotte Rechenmacher, Dr | Praxis Dr. Rechenmacher, Oldenburg | Principal Investigator |
| Georgieva, Dr. | Karolinska Institute, Stockholm | Principal Investigator |
| Spyridon Kilaidakis, Dr. | Region Örebro County | Principal Investigator |
| Claus Schubert, Dr | Substitutionsambulanz Geinhausen | Principal Investigator |
| Chaim Jellinek | a.i.d., Ambulanz fur integrierte Drogenhilfe | Principal Investigator |
| Karl Heinz Meller, Dr | Praxis Dr. Meller | Principal Investigator |
| Linz |
| 4020 |
| Austria |
| Prof. Dr. Wurst | Salzburg | 5020 | Austria |
| Prof. Wolzt | Vienna | 1090 | Austria |
| Dr. Vehak | Prague | 1400 | Czechia |
| Dr. Stankova | Ústí nad Labem | 40113 | Czechia |
| Dr. Tietje | Bremen | 28719 | Germany |
| Prof. Scherbaum | Essen | 45147 | Germany |
| Dr. Weber | Kassel | 34117 | Germany |
| PD. Dr. Pogarell | Munich | 80336 | Germany |
| Dr. Rechenmacher | Oldenburg | 26121 | Germany |
| Dr. Boniakowski | Regensburg | 93051 | Germany |
| Dr. Issler | Stuttgart | 70197 | Germany |
| Dr. Kilaidakis | Örebro | 70185 | Sweden |
| Dr. Georgieva | Stockholm | 17176 | Sweden |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |