Transfer of Subjects From Subutex/Suboxone to RBP-6300

Indivior

Status and phase: Completed; Phase 2

Conditions: Opioid Related Disorder

Treatments: Drug: Subutex®/Suboxone®; Drug: Placebo for Subutex®/Suboxone®; Drug: Placebo for RBP-6300; Drug: RBP-6300

Study type: Interventional

Funder types: Industry

Identifiers

NCT01582347

RB-UK-11-0017

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 2 patient groups

RBP-6300

Experimental group

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.

Treatment:

Drug: RBP-6300

Drug: Placebo for Subutex®/Suboxone®

Drug: Placebo for RBP-6300

Drug: Subutex®/Suboxone®

Subutex®/Suboxone®

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo for RBP-6300

Drug: Subutex®/Suboxone®