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Transfer of Subjects From Subutex/Suboxone to RBP-6300

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.
ClinicalTrials.gov Identifier:
NCT01582347
First received: April 18, 2012
Last updated: January 19, 2017
Last verified: January 2017
  Purpose
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: Subutex®/Suboxone® Drug: Placebo for RBP-6300 Drug: Placebo for Subutex®/Suboxone® Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
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
Experimental: 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.
Drug: 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.

Other Names:
  • buprenorphine hemiadipate HCl
  • naloxone HCl
Drug: 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.

Other Names:
  • buprenorphine
  • naloxone
Drug: 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.

Other Name: placebo
Drug: Placebo for Subutex®/Suboxone®
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
Other Name: placebo
Active Comparator: 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.
Drug: 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.

Other Names:
  • buprenorphine
  • naloxone
Drug: 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.

Other Name: placebo

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT01582347

Locations
Austria
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
Germany
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
Sweden
Dr. Kilaidakis
Orebro, Sweden, 70185
Dr. Georgieva
Stockholm, Sweden, 17176
Sponsors and Collaborators
Indivior Inc.
Investigators
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.
ClinicalTrials.gov Identifier: NCT01582347     History of Changes
Other Study ID Numbers: RB-UK-11-0017
Study First Received: April 18, 2012
Last Updated: January 19, 2017

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
Buprenorphine
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on June 27, 2017