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RECRUITING Phase 4

A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder

NCT04375033 · View on ClinicalTrials.gov ↗

Study Summary

VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous formulation of buprenorphine at a target dose of 300mg is superior in retaining Veterans in opioid treatment and in sustaining opioid abstinence compared to the daily sublingual (under the tongue) buprenorphine formulation at a target dose of 4-32 mg (standard of care). This is an open-label, randomized, controlled trial including 952 Veterans with opioid use disorder (OUD) recruited over 7 years and followed actively for 52 weeks. There are a number of secondary objectives that will be studied as well and include: comorbid substance use, both non-fatal and fatal opioid overdose, HIV and Hepatitis B (HBV) and C (HCV) testing results and risk behaviors, incarceration, quality of life, psychiatric symptoms of depression and posttraumatic stress disorder, housing status, dental health and utilization, and cost-effectiveness.

Conditions Studied

Interventions

  • DRUG Sublingual buprenorphine with naloxone
  • DRUG Injectable subcutaneous buprenorphine

Study Locations (20)

California

  • VA Long Beach Healthcare System, Long Beach, CA — Long Beach
  • VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
  • San Francisco VA Medical Center, San Francisco, CA — San Francisco

Connecticut

  • CERC (VISN1, West Haven, CT) — West Haven
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Florida

  • Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines
  • North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville

Ohio

  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
  • Dayton VA Medical Center, Dayton, OH — Dayton

Pennsylvania

  • Philadelphia MultiService Center, Philadelphia, PA — Philadelphia
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Alabama

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa

Arizona

  • Phoenix VA Health Care System, Phoenix, AZ — Phoenix

Delaware

  • Wilmington VA Medical Center, Wilmington, DE — Wilmington

Trial Details

FieldValue
Enrollment Target 952 participants
Start Date 2020-11-03
Est. Completion 2029-05-31
Phase Phase 4

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04375033

The ClinicalTrials.gov registry entry for NCT04375033 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 952 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions — of which Sublingual buprenorphine with naloxone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04375033 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04375033 about?

NCT04375033 is a clinical study titled "A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder". VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous formulation of buprenorphine at a target dose of 300mg is superior in retaining Veterans in opioid treatment and in sustaining opioid abstinence compared to the daily sublingual (under the tongue) buprenorphine formulation...

What is the current status of trial NCT04375033?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 952 participants. The study started on 2020-11-03. Estimated completion is 2029-05-31.

What conditions does trial NCT04375033 study?

This clinical trial studies the following conditions: Opioid Use Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04375033?

The interventions under investigation include: Sublingual buprenorphine with naloxone (DRUG), Injectable subcutaneous buprenorphine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04375033?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04375033 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial