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Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users

NCT04995029 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 785

Last updated 2026-02-06

Study results available
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Summary

The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.

The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks.

Conditions

  • Moderate to Severe Opioid-use Disorder

Interventions

DRUG

Transmucosal Buprenorphine

Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)

DRUG

Extended-release Buprenorphine

Administered by subcutaneous injection

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Global Director Clinical Development · Indivior Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2024-06-26
Completion
2024-06-26
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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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 NCT04995029 on ClinicalTrials.gov