Transfer of Subjects From Subutex/Suboxone to RBP-6300

This study has been completed.
Information provided by (Responsible Party):
Indivior Inc. Identifier:
First received: April 18, 2012
Last updated: August 7, 2015
Last verified: May 2015
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

Condition Intervention Phase
Opioid Related Disorder
Drug: RBP-6300
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Indivior Inc.:

Primary Outcome Measures:
  • Treatment [ Time Frame: 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:
  • Assess the overall clinical response to RBP-6300 [ Time Frame: one year ]
    One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events

Enrollment: 143
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RBP-6300
Transfer and transition
Drug: RBP-6300
8, 16, 24mg daily, for 30 days
Placebo Comparator: Placebo
8mg to 24mg 3 day single blind transition phase placebo matching RBP-6300 and active Subutex/Suboxone
Drug: Placebo
8, 16, 24mg daily, 30 days


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01582347

Prof. Dr. Fleischhacker
Austria, Austria, 6020
Dr. Lindenbauer
Linz, Austria, 4020
Prof. Dr. Wurst
Salzburg, Austria, 5020
Prof. Wolzt
Wien, Austria, 1090
Czech Republic
Dr. Vehak
Prague, Czech Republic, 1400
Dr. Stankova
Usti nad Labem, Czech Republic, 40113
Dr. Tietje
Bremen, Germany, 28719
Prof. Scherbaum
Essen, Germany, 45147
Dr. Weber
Kassel, Germany, 34117
PD. Dr. Pogarell
Munich, Germany, 80336
Dr. Rechenmacher
Oldenburg, Germany, 26121
Dr. Boniakowski
Regensburg, Germany, 93051
Dr. Issler
Stuttgart, Germany, 70197
Dr. Kilaidakis
Orebro, Sweden, 70185
Dr. Georgieva
Stockholm, Sweden, 17176
Sponsors and Collaborators
Indivior Inc.
Principal Investigator: 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
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
  More Information

Responsible Party: Indivior Inc. Identifier: NCT01582347     History of Changes
Other Study ID Numbers: RB-UK-11-0017 
Study First Received: April 18, 2012
Last Updated: August 7, 2015

Keywords provided by Indivior Inc.:
Opioid dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on January 19, 2017