Transfer of Subjects From Subutex/Suboxone to RBP-6300

NCT01582347 | Completed Phase 2 DMC

• 1 other identifier: RB-UK-11-0017
• Study Type: interventional
• Target: 143
• Locations: 4 countries
• Sites: 15

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

Conditions

Opioid Related Disorder

Keywords

Opioid dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess the overall clinical response to RBP-6300

  one year

Study Arms (2)

RBP-6300

EXPERIMENTAL

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; Drug: Subutex®/Suboxone®; Drug: Placebo for RBP-6300; Drug: Placebo for Subutex®/Suboxone®

Subutex®/Suboxone®

ACTIVE COMPARATOR

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®; Drug: Placebo for RBP-6300

Interventions

RBP-6300 DRUG

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.

Also known as: buprenorphine hemiadipate HCl, naloxone HCl

RBP-6300

Subutex®/Suboxone® DRUG

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.

Also known as: buprenorphine, naloxone

RBP-6300; Subutex®/Suboxone®

Placebo for RBP-6300 DRUG

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.

Also known as: placebo

RBP-6300; Subutex®/Suboxone®

Placebo for Subutex®/Suboxone® DRUG

Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.

Also known as: placebo

RBP-6300

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (15)

Prof. Dr. Fleischhacker

Austria, 6020, Austria

Location

Dr. Lindenbauer

Linz, 4020, Austria

Location

Prof. Dr. Wurst

Salzburg, 5020, Austria

Location

Prof. Wolzt

Vienna, 1090, Austria

Location

Dr. Vehak

Prague, 1400, Czechia

Location

Dr. Stankova

Ústí nad Labem, 40113, Czechia

Location

Dr. Tietje

Bremen, 28719, Germany

Location

Prof. Scherbaum

Essen, 45147, Germany

Location

Dr. Weber

Kassel, 34117, Germany

Location

PD. Dr. Pogarell

Munich, 80336, Germany

Location

Dr. Rechenmacher

Oldenburg, 26121, Germany

Location

Dr. Boniakowski

Regensburg, 93051, Germany

Location

Dr. Issler

Stuttgart, 70197, Germany

Location

Dr. Kilaidakis

Örebro, 70185, Sweden

Location

Dr. Georgieva

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naloxone; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 20, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

SE (2); DE (7); CZ (2); AU (4)