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A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Sponsor: VA Office of Research and Development
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.
Official title: CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
952
Start Date
2020-11-03
Completion Date
2029-05-31
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Sublingual buprenorphine with naloxone
The combination SL-containing buprenorphine contains naloxone in a ratio of 4:1 buprenorphine:naloxone. Participants will be given a 28-prescription at each 28-day visit through Week 48.
Injectable subcutaneous buprenorphine
Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously at each 28-day visit through Week 48.
Locations (25)
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Wilmington VA Medical Center, Wilmington, DE
Wilmington, Delaware, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 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
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, 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
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States