Indivior Inc.
Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in 4 different quadrants of the abdomen for treatment of opioid use disorder (OUD). Injection locations are rotated to minimize irritation. Having 1 or more alternate injection sites is desirable for patients who may be taking SUBLOCADE for extended durations, based upon clinical response. 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).
Opioid Use Disorder
Buprenorphine Extended-Release Injection
Phase 4
Study Type : | Interventional |
Estimated Enrollment : | 88 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults |
Actual Study Start Date : | March 1, 2023 |
Estimated Primary Completion Date : | November 1, 2023 |
Estimated Study Completion Date : | November 1, 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Extended-release Buprenorphine: Abdomen Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1. |
Drug: Buprenorphine Extended-Release Injection |
Experimental: Extended-release Buprenorphine: Upper Arm Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1. |
Drug: Buprenorphine Extended-Release Injection |
Experimental: Extended-release Buprenorphine: Buttocks Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1. |
Drug: Buprenorphine Extended-Release Injection |
Experimental: Extended-release Buprenorphine: Thigh Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1. |
Drug: Buprenorphine Extended-Release Injection |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Not yet recruiting
Research Centers of America
Hollywood, florida, United States, 33024
Not yet recruiting
Miami Lakes Medical Research
Miami Lakes, florida, United States, 33016
Not yet recruiting
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States, 73112
Not yet recruiting
InSite Clinical Research, LLC
DeSoto, Texas, United States, 75115
Not yet recruiting
Pillar Clinical Research, LLC
Richardson, Texas, United States, 75080