Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2012-03-31
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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®
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
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®
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
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®
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
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.
Interventions
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RBP-6300
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®
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
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®
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Indivior Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Norbert Scherbaum, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University, Duisburg-Essen, Germany
Michael Wolzt, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien
Wolfgang Fleischhacker, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University Innsbruck
Vratislav Rehak, Dr.
Role: PRINCIPAL_INVESTIGATOR
Remedis s.r.o., Prague
Zdenka Stankova, Dr.
Role: PRINCIPAL_INVESTIGATOR
Masaryk Hospital Usti nad Labem
Oliver Pogarell, PD. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University, Munich
Bernd Weber, Dr.
Role: PRINCIPAL_INVESTIGATOR
Praxis Dr. Bernd Weber am Koenigsplatz Schwerpunkprax is fur Suchtmedizin, Kassel
Edith Issler, Dr.
Role: PRINCIPAL_INVESTIGATOR
Infectomed GbR Zentrum fuer medizinische Studien, Stuttgart
Wieland Tietje, Dr.
Role: PRINCIPAL_INVESTIGATOR
Drs. Tieje, Heer & Koc, Bremen
Eduard Boniakowski, Dr.
Role: PRINCIPAL_INVESTIGATOR
Psychosoziale Begleitung - Praxis Boniakowski, Regensburg
Charlotte Rechenmacher, Dr
Role: PRINCIPAL_INVESTIGATOR
Praxis Dr. Rechenmacher, Oldenburg
Georgieva, Dr.
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute, Stockholm
Spyridon Kilaidakis, Dr.
Role: PRINCIPAL_INVESTIGATOR
Region Örebro County
Claus Schubert, Dr
Role: PRINCIPAL_INVESTIGATOR
Substitutionsambulanz Geinhausen
Chaim Jellinek
Role: PRINCIPAL_INVESTIGATOR
a.i.d., Ambulanz fur integrierte Drogenhilfe
Karl Heinz Meller, Dr
Role: PRINCIPAL_INVESTIGATOR
Praxis Dr. Meller
Locations
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Prof. Dr. Fleischhacker
Austria, , Austria
Dr. Lindenbauer
Linz, , Austria
Prof. Dr. Wurst
Salzburg, , Austria
Prof. Wolzt
Vienna, , Austria
Dr. Vehak
Prague, , Czechia
Dr. Stankova
Ústí nad Labem, , Czechia
Dr. Tietje
Bremen, , Germany
Prof. Scherbaum
Essen, , Germany
Dr. Weber
Kassel, , Germany
PD. Dr. Pogarell
Munich, , Germany
Dr. Rechenmacher
Oldenburg, , Germany
Dr. Boniakowski
Regensburg, , Germany
Dr. Issler
Stuttgart, , Germany
Dr. Kilaidakis
Örebro, , Sweden
Dr. Georgieva
Stockholm, , Sweden
Countries
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Other Identifiers
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RB-UK-11-0017
Identifier Type: -
Identifier Source: org_study_id
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