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

NCT05704543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-01-07

Study results available
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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

Interventions

DRUG

Buprenorphine Extended-Release Injection

Administered as a subcutaneous injection.

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Global Director Clinical Development · Indivior Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05704543 on ClinicalTrials.gov