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NCT04375033 · ClinicalTrials.gov registry record · Phase 4
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
A Phase 4 study of Opioid Use Disorder, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 952
- Enrollment target
- 20
- Study locations
NCT04375033: Recruiting Phase 4 study of Opioid Use Disorder, sponsored by VA Office of Research and Development.
NCT04375033 is a Phase 4 study of Opioid Use Disorder that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 952 participants, below the 4,653-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375033, a Phase 4 study of Opioid Use Disorder, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 952 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Measured by receipt of prescribed study drug (via prescription or admission) and assessed via local study team records. Retention-in-treatment is a highly sensitive indicator of effective treatment as discontinuation is strongly associated with recurrence of use to opioids and risk for accidental drug poisoning.
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
| Field | Value |
|---|---|
| Enrollment Target | 952 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 4 |
What NCT04375033 shows while recruiting
NCT04375033 is an interventional study that assigns participants to a tested intervention. The registered 952 participants enrollment target is mid-sized for trials with a published cap, below the 4,653-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (80% lower).
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.
NCT04375033 names 20 study sites across 14 states, led by California, Connecticut, Florida.
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.
What interventions are being tested in trial NCT04375033?
The interventions under investigation include: Sublingual buprenorphine with naloxone (DRUG), Injectable subcutaneous buprenorphine (DRUG).
Who is sponsoring clinical trial NCT04375033?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04375033's enrollment target sits among peer trials
952 20th of 257 higher than 238 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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