Opioid Related Disorder
Conditions
Keywords
Opioid dependence
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.
Interventions
DRUGRBP-6300
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.
DRUGSubutex®/Suboxone®
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.
DRUGPlacebo for RBP-6300
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.
DRUGPlacebo for Subutex®/Suboxone®
Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
Sponsors
Indivior Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess the overall clinical response to RBP-6300 | one year | One of the secondary objectives is to evaluate the safety and tolerability of RBP-6300 in terms of adverse events |
Countries
Austria, Czechia, Germany, Sweden
Outcome results
None listed