Clinical Trial: Transfer of Subjects From Subutex/Suboxone to RBP-6300

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Subje

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

Detailed Summary:

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.


Sponsor: Indivior Inc.

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: Indivior Inc.

Dates:
Date Received: April 18, 2012
Date Started: March 2012
Date Completion:
Last Updated: January 19, 2017
Last Verified: January 2017