Clinical trial NCT01582347: Transfer of Subjects From Subutex/Suboxone to RBP-6300
Official title: A Randomized, Double-blind, Double-dummy, Active-drug-controlled, Parallel-group, Multicentre Acceptability and Safety Study of the Transfer From Subutex/Suboxone to RBP-6300 in Opioid-dependent Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Related Disorder
Keywords: Opioid dependence
Lead sponsor: Indivior Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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:

* 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)

Primary outcomes:
measure: Treatment
timeFrame: 7 days
Secondary outcomes:
measure: Assess the overall clinical response to RBP-6300
timeFrame: one year
Other outcomes:
Locations:
city: Austria
country: Austria
facility: Prof. Dr. Fleischhacker
city: Linz
country: Austria
facility: Dr. Lindenbauer
city: Salzburg
country: Austria
facility: Prof. Dr. Wurst
city: Wien
country: Austria
facility: Prof. Wolzt
city: Prague
country: Czech Republic
facility: Dr. Vehak
city: Usti nad Labem
country: Czech Republic
facility: Dr. Stankova
city: Bremen
country: Germany
facility: Dr. Tietje
city: Essen
country: Germany
facility: Prof. Scherbaum
city: Kassel
country: Germany
facility: Dr. Weber
city: Munich
country: Germany
facility: PD. Dr. Pogarell
city: Oldenburg
country: Germany
facility: Dr. Rechenmacher
city: Regensburg
country: Germany
facility: Dr. Boniakowski
city: Stuttgart
country: Germany
facility: Dr. Issler
city: Orebro
country: Sweden
facility: Dr. Kilaidakis
city: Stockholm
country: Sweden
facility: Dr. Georgieva
Study officials:
affiliation: Medical University, Duisburg-Essen, Germany
name: Norbert Scherbaum, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien
name: Michael Wolzt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Innsbruck
name: Wolfgang Fleischhacker, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Remedis s.r.o., Prague
name: Vratislav Rehak, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Masaryk Hospital Usti nad Labem
name: Zdenka Stankova, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University, Munich
name: Oliver Pogarell, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxis Dr. Bernd Weber am Koenigsplatz Schwerpunkprax is fur Suchtmedizin, Kassel
name: Bernd Weber, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectomed GbR Zentrum fuer medizinische Studien, Stuttgart
name: Edith Issler, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Drs. Tieje, Heer & Koc, Bremen
name: Wieland Tietje, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Psychosoziale Begleitung - Praxis Boniakowski, Regensburg
name: Eduard Boniakowski, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxis Dr. Rechenmacher, Oldenburg
name: Charlotte Rechenmacher, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institute, Stockholm
name: Georgieva, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Region Örebro County
name: Spyridon Kilaidakis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Substitutionsambulanz Geinhausen
name: Claus Schubert, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: a.i.d., Ambulanz fur integrierte Drogenhilfe
name: Chaim Jellinek
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxis Dr. Meller
name: Karl Heinz Meller, Dr
role: PRINCIPAL_INVESTIGATOR
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