This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.
Vince & Associates Clinical Research
Overland Park, Kansas, United States
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Relative bioavailability will be assessed using AUC0-28days.
Time frame: Day 1 to Day 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Relative bioavailability will also be assessed using Cmax
Time frame: Day 1 to Day 57
Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine
Time frame: Day 1 to Day 29
Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine
Time frame: Day 1 to Day 57
Participants with Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 57
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