NCT03993392

SUBLOCADE Rapid Initiation Study

An Open-label, Rapid Initiation Study for Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.

Detailed description

Currently patients who are appropriate candidates for SUBLOCADE™ injection for subcutaneous (SC) use must initiate treatment with TM buprenorphine for a minimum of 7 days before receiving their first injection. This study is to evaluate the safety and tolerability of starting SUBLOCADE treatment following a shorter period. Adults with moderate to severe opioid use disorder (OUD) not currently receiving medication assisted treatment will be recruited to participate. Prior to receiving TM buprenorphine, subjects will report their last opioid use and be experiencing at least mild withdrawal. Subjects will receive at least one dose of TM buprenorphine to ensure tolerability and that they show no evidence of precipitated withdrawal. If no evidence of intolerability or no precipitated withdrawal occurs, subjects will receive a single injection of SUBLOCADE and remain in the clinic for approximately 48 hours after the injection to assess for safety and tolerability.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	TM buprenorphine	4mg TM buprenorphine, investigator choice as to brand
DRUG	SUBLOCADE	300mg subcutaneous injection

Timeline

• Start date: 2019-08-29
• Primary completion: 2019-12-26
• Completion: 2019-12-26
• First posted: 2019-06-20
• Last updated: 2025-03-25
• Results posted: 2020-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study