Transfer of Subjects From Subutex/Suboxone to RBP-6300

Opioid Related Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582347
• Other study ID #: RB-UK-11-0017
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: January 19, 2017
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2017
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Related Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Austria	Prof. Dr. Fleischhacker	Austria
Austria	Dr. Lindenbauer	Linz
Austria	Prof. Dr. Wurst	Salzburg
Austria	Prof. Wolzt	Wien
Czech Republic	Dr. Vehak	Prague
Czech Republic	Dr. Stankova	Usti nad Labem
Germany	Dr. Tietje	Bremen
Germany	Prof. Scherbaum	Essen
Germany	Dr. Weber	Kassel
Germany	PD. Dr. Pogarell	Munich
Germany	Dr. Rechenmacher	Oldenburg
Germany	Dr. Boniakowski	Regensburg
Germany	Dr. Issler	Stuttgart
Sweden	Dr. Kilaidakis	Orebro
Sweden	Dr. Georgieva	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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