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Transfer of Subjects From Subutex/Suboxone to RBP-6300

Primary Purpose

Opioid Related Disorder

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RBP-6300

Subutex®/Suboxone®

Placebo for RBP-6300

Placebo for Subutex®/Suboxone®

About this trial

This is an interventional treatment trial for Opioid Related Disorder focused on measuring Opioid dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RBP-6300

Subutex®/Suboxone®

Arm Description

During the Double-Blind Transfer Period (Days 1-7), participants take RBP-6300 at a level (either 10, 20 or 30 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for Subutex®/Suboxone®. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000.

During the Double-Blind Transfer Period (Days 1-7), participants take Subutex®/Suboxone® at a level (either 8, 16 or 240 mg/day) equivalent to dosing during the Run-In Period, plus Placebo for RBP-6000. This is followed by a 3-day Transition Period (Days 8-10) in which participants take active Subutex®/Suboxone® equal to the dose taken during the Run-In Period plus placebo matching RBP-6000.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01582347

First Posted

April 18, 2012

Last Updated

January 19, 2017

Sponsor

Indivior Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01582347

Brief Title

Transfer of Subjects From Subutex/Suboxone to RBP-6300

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indivior Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Related Disorder

Keywords

Opioid dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RBP-6300

Arm Type

Experimental

Arm Description

Arm Title

Subutex®/Suboxone®

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

RBP-6300

Other Intervention Name(s)

buprenorphine hemiadipate HCl, naloxone HCl

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Subutex®/Suboxone®

Other Intervention Name(s)

buprenorphine, naloxone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo for RBP-6300

Other Intervention Name(s)

placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo for Subutex®/Suboxone®

Other Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment

Description

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 Outcome Measure Information:

Title

Assess the overall clinical response to RBP-6300

Description

One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: