Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in the abdomen for treatment of opioid use disorder (OUD). Having alternative injection sites is desirable to provide additional flexibility to patients, particularly for those who may prefer less visible or more convenient injection locations. The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Administered as a subcutaneous injection.
Artemis Institute for Clinical Research
San Diego, California, United States
Research Centers of America
Hollywood, Florida, United States
Miami Lakes Medical Research
Miami Lakes, Florida, United States
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Area Under the Plasma Concentration-time Curve From Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Time frame: Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29
Participants With Treatment-emergent Adverse Events
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events Identified as Injection Site Reactions
Time frame: 28 days
Number of Participants With Treatment-emergent Serious Adverse Events
Time frame: 28 days
Injection Site Grading
Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale.
Time frame: Day 1 at 10 minutes and 2 hours post dosing
Injection Site Pain
Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.
Time frame: Day 1 at 1, 5, 10, 15, and 30 minutes post dosing
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