Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04375033 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: VA-BRAVE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 12 words Secondary endpoints revised (10) · Site details revised at 1 of 25 sitesv30 Show 2 more changesShow less
    • Secondary endpoints revised (10)
    • Site details revised at 1 of 25 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 3 of 25 sitesv29
  3. Study description shortened, about 11 words Publications: details revised at 1 of 1 entry · Eligibility criteria shortened, about 5 wordsv28 Show 2 more changesShow less
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Site details revised at 7 of 25 sites Publications: details revised at 1 of 1 entryv27 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  5. Site contacts updated at 1 of 25 sitesv26
Show 24 earlier versionsHide 24 earlier versions
  1. Study description expanded, about 1 wordv25 See this version in full on ClinicalTrials.gov ↗
  2. Study description revised Site details revised at 1 of 25 sites · Eligibility criteria expanded, about 4 wordsv24 Show 2 more changesShow less
    • Site details revised at 1 of 25 sites
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 25 sitesv23
  4. Re-verified, no change to tracked fieldsv22
  5. Site details revised at 1 of 25 sites Publications: details revised at 1 of 1 entryv21 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  6. Site details revised at 1 of 25 sites Publications: details revised at 1 of 1 entryv20 Show 1 more changeShow less
    • Publications: details revised at 1 of 1 entry
  7. Primary completion date: Nov 3, 2024 to Sep 30, 2028 Completion date: Nov 4, 2025 to May 31, 2029 · Site details revised at 2 of 25 sitesv19 Show 2 more changesShow less
    • Completion date: Nov 4, 2025 to May 31, 2029
    • Site details revised at 2 of 25 sites
  8. Study sites: 24 to 25v18
  9. Study description revisedv17 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 1 of 24 sitesv16
  11. Primary completion date: Nov 3, 2023 to Nov 3, 2024 Completion date: Nov 4, 2024 to Nov 4, 2025 · Eligibility criteria expanded, about 47 words · Secondary endpoints: 9 to 10 · 1 morev15 Show 4 more changesShow less
    • Completion date: Nov 4, 2024 to Nov 4, 2025
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 9 to 10
    • Publications: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 23 to 24v14
  13. Study sites: 21 to 23v13
  14. Site details revised at 13 of 21 sitesv12
  15. Enrollment target: 900 to 952 Secondary endpoints: 4 to 9v11 Show 1 more changeShow less
    • Secondary endpoints: 4 to 9

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites revised (21)v10 See this version in full on ClinicalTrials.gov ↗
  17. Site contacts updated at 1 of 21 sitesv9
  18. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 16, 2023 to Nov 3, 2023 · Completion date: Oct 14, 2024 to Nov 4, 2024 · Start date changed from estimate of Oct 15, 2020 to Nov 3, 2020 · 1 morev8 Show 4 more changesShow less
    • Primary completion date: Oct 16, 2023 to Nov 3, 2023
    • Completion date: Oct 14, 2024 to Nov 4, 2024
    • Start date changed from estimate of Oct 15, 2020 to Nov 3, 2020
    • Site details revised at 21 of 21 sites
  19. Primary completion date: Oct 9, 2023 to Oct 16, 2023 Start date: Oct 5, 2020 to Oct 15, 2020v7 Show 1 more changeShow less
    • Start date: Oct 5, 2020 to Oct 15, 2020
  20. Primary completion date: Sep 15, 2023 to Oct 9, 2023 Completion date: Sep 16, 2024 to Oct 14, 2024 · Start date: Sep 14, 2020 to Oct 5, 2020v6 Show 2 more changesShow less
    • Completion date: Sep 16, 2024 to Oct 14, 2024
    • Start date: Sep 14, 2020 to Oct 5, 2020
  21. Primary completion date: Sep 1, 2023 to Sep 15, 2023 Completion date: Aug 30, 2024 to Sep 16, 2024 · Start date: Sep 1, 2020 to Sep 14, 2020v5 Show 2 more changesShow less
    • Completion date: Aug 30, 2024 to Sep 16, 2024
    • Start date: Sep 1, 2020 to Sep 14, 2020
  22. Primary completion date: Jul 31, 2023 to Sep 1, 2023 Completion date: Aug 2, 2024 to Aug 30, 2024 · Start date: Aug 3, 2020 to Sep 1, 2020v4 Show 2 more changesShow less
    • Completion date: Aug 2, 2024 to Aug 30, 2024
    • Start date: Aug 3, 2020 to Sep 1, 2020
  23. Start date: Jul 1, 2020 to Aug 3, 2020 Primary completion date: Jun 30, 2023 to Jul 31, 2023 · Completion date: Jun 28, 2024 to Aug 2, 2024v3 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2023 to Jul 31, 2023
    • Completion date: Jun 28, 2024 to Aug 2, 2024
  24. Start date: Jun 1, 2020 to Jul 1, 2020 Primary completion date: May 31, 2023 to Jun 30, 2023 · Completion date: May 31, 2024 to Jun 28, 2024v2 Show 2 more changesShow less
    • Primary completion date: May 31, 2023 to Jun 30, 2023
    • Completion date: May 31, 2024 to Jun 28, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous formulation of buprenorphine at a target dose of 300 milligrams (mg) 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.
Trial Details
NCT Number NCT04375033
Lead Sponsor VA Office of Research and Development
Conditions Opioid Use Disorder
Enrollment 952 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov