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Completed

NCT Number: NCT01582347

Transfer of Subjects From Subutex/Suboxone to RBP-6300

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

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Key information

Conditions

Opioid Related Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prof. Dr. Fleischhacker, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: buprenorphine hemiadipate HCl, naloxone HCl

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.

Other names: buprenorphine, naloxone

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.

Other names: placebo

Placebo for Subutex®/Suboxone®

Drug

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

Other names: placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indivior Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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