Transfer of Subjects From Subutex/Suboxone to RBP-6300

Indivior Inc.143 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

143

Conditions

Opioid Related Disorder

Interventions

RBP-6300DRUG

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®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.

Placebo for RBP-6300DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (15)

Prof. Dr. Fleischhacker

Austria, Austria

Dr. Lindenbauer

Linz, Austria

Prof. Dr. Wurst

Salzburg, Austria

Outcomes

Primary Outcomes

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

Time frame: 7 days

Secondary Outcomes

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

Time frame: one year

Data from ClinicalTrials.gov

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