NCT05704543

Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine Extended-Release Injection	Administered as a subcutaneous injection.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2023-01-30
• Last updated: 2025-01-07
• Results posted: 2025-01-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study