Transfer of Subjects From Subutex/Suboxone to RBP-6300

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

Interventions

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.

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.

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.

DRUG

Placebo for Subutex®/Suboxone®

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

Sponsors & Collaborators

• Indivior Inc.

  lead INDUSTRY

Principal Investigators

• Norbert Scherbaum, Prof. Dr. · Medical University, Duisburg-Essen, Germany

• Michael Wolzt, Prof. Dr. · Univ.-Klinik fur Klinische Pharmakologie, AKH Wien, Wien

• Wolfgang Fleischhacker, Prof. Dr. · Medical University Innsbruck

• Vratislav Rehak, Dr. · Remedis s.r.o., Prague

• Zdenka Stankova, Dr. · Masaryk Hospital Usti nad Labem

• Oliver Pogarell, PD. Dr. · Medical University, Munich

• Bernd Weber, Dr. · Praxis Dr. Bernd Weber am Koenigsplatz Schwerpunkprax is fur Suchtmedizin, Kassel

• Edith Issler, Dr. · Infectomed GbR Zentrum fuer medizinische Studien, Stuttgart

• Wieland Tietje, Dr. · Drs. Tieje, Heer & Koc, Bremen

• Eduard Boniakowski, Dr. · Psychosoziale Begleitung - Praxis Boniakowski, Regensburg

• Charlotte Rechenmacher, Dr · Praxis Dr. Rechenmacher, Oldenburg

• Georgieva, Dr. · Karolinska Institute, Stockholm

• Spyridon Kilaidakis, Dr. · Region Örebro County

• Claus Schubert, Dr · Substitutionsambulanz Geinhausen

• Chaim Jellinek · a.i.d., Ambulanz fur integrierte Drogenhilfe

• Karl Heinz Meller, Dr · Praxis Dr. Meller

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2012-11-30

Completion

2012-11-30

Countries

• Austria
• Czechia
• Germany
• Sweden

Study Locations