A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Recruiting now · Phase 4
Conditions studied: Opioid Use Disorder
In brief
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.
Key facts
- Study ID
- NCT04375033
- Run by
- VA Office of Research and Development
- People needed
- 952
- Starts
- 2020-11-03
- Expected to finish
- 2029-05-31
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has used opioids within 30 days prior to consent or within 30 days prior to entry into a supervised setting -- e.g., opioid use within the 30 days prior to recent (<30 days) incarceration, entry into a detoxification facility, or entry into an inpatient hospital setting
- Have started or are in the process of starting on MOUD via clinical induction on SL-BUP/NLX
- Meets DSM-5 criteria for moderate to severe OUD based on the Mini-International Neuropsychiatric Interview
- Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
You may not qualify if…
- Is a Veteran less than 18 years of age
- For Veterans of childbearing potential (a premenopausal person capable of becoming pregnant), pregnancy, breastfeeding, and/or failure to practice an effective method of birth control
- Failure to reach maintenance dose of 4mg - 32mg SL-BUP/NLX in 45 days or less.
- Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or XR-NTX) continuously >45 days prior to randomization
- Has a history of significant adverse effects from buprenorphine and/or naloxone
- Has experienced (within the past 2 weeks) recent suicidal or homicidal ideation that requires acute treatment or hospitalization.
- Is unwilling or unable to provide consent
- Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI SHUD module
- Anuria and/or dialysis
- Current moderate to severe COVID-19 symptoms with a risk of intubation or critical illness.
- Medical, psychiatric, behavioral, or logistical condition which, in the judgement of the Local Site Investigator (LSI) or Co-Investigator (Co-I), requires a higher level of acute care and/or makes it unlikely the patient can participate in or complete the 52-week active phase of the study.
- Is actively participating in an interventional clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained.
Where it is running
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (enrolling)
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States (enrolling)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
- Wilmington VA Medical Center, Wilmington, DE — Wilmington, Delaware, United States (enrolling)
- Hampton VA Medical Center, Hampton, VA — Hampton, Virginia, United States (enrolling)
- Salem VA Medical Center, Salem, VA — Salem, Virginia, United States (enrolling)
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (enrolling)
- Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines, Florida, United States (enrolling)
- Clement J. Zablocki VA Medical Center, Milwaukee, WI — Milwaukee, Wisconsin, United States (enrolling)
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (enrolling)
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (enrolling)
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (enrolling)
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (enrolling)
- Dayton VA Medical Center, Dayton, OH — Dayton, Ohio, United States (enrolling)
- Philadelphia MultiService Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States (enrolling)
- CERC (VISN1, West Haven, CT) — West Haven, Connecticut, United States (enrolling)
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
- Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
- Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States
- White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States
- Huntington VA Medical Center, Huntington, WV — Huntington, West Virginia, United States
Full record on ClinicalTrials.gov
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