Condition: Opioid Use Disorder · Sponsor: VA Office of Research and Development
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.
This description comes directly from the study's public registry record.
Avron Spiro, PhD MS · (857) 364-2888 · avron.spiro@va.gov
Melynn Nuite, RN BS CCRC · (617) 232-9500 · Melynn.Nuite@va.gov
Always discuss trial participation with your own doctor first.
| Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa, Alabama, United States | Terminated |
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix, Arizona, United States | Recruiting |
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach, California, United States | Recruiting |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto, California, United States | Recruiting |
| San Francisco VA Medical Center, San Francisco, CA | San Francisco, California, United States | Recruiting |
| CERC (VISN1, West Haven, CT) | West Haven, Connecticut, United States | Recruiting |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven, Connecticut, United States | Active Not Recruiting |
| Wilmington VA Medical Center, Wilmington, DE | Wilmington, Delaware, United States | Recruiting |
| Bay Pines VA Healthcare System, Pay Pines, FL | Bay Pines, Florida, United States | Recruiting |
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville, Florida, United States | Recruiting |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston, Massachusetts, United States | Terminated |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis, Minnesota, United States | Terminated |
+ 13 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04375033