Transfer of Subjects From Subutex/Suboxone to RBP-6300

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

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

Study Overview

• Status: Completed
• Conditions: Opioid Related Disorder
• Intervention / Treatment: Drug: RBP-6300; Drug: Subutex®/Suboxone®; Drug: Placebo for RBP-6300; Drug: Placebo for Subutex®/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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: placebo; Drug: Placebo for Subutex®/Suboxone®; Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.; Other Names: 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 Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Opioid dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: RB-UK-11-0017