Actively Recruiting
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Led by VA Office of Research and Development · Updated on 2026-01-12
952
Participants Needed
25
Research Sites
447 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Used opioids within 30 days before consent or before entering a supervised setting like incarceration or detox
- Started or in the process of starting medication for opioid use disorder with sublingual buprenorphine with naloxone
- Meet DSM-5 criteria for moderate to severe opioid use disorder confirmed by Mini-International Neuropsychiatric Interview
- Seeking treatment for opioid use disorder and willing to accept partial-agonist-based therapy
You will not qualify if you...
- Under 18 years of age
- For those who can become pregnant: pregnancy, breastfeeding, or not using effective birth control
- Unable to reach maintenance dose of 4-32 mg sublingual buprenorphine with naloxone within 45 days
- Taking other prescribed maintenance medications for opioid use disorder continuously for more than 45 days before randomization
- History of serious side effects from buprenorphine or naloxone
- Recent (past 2 weeks) suicidal or homicidal thoughts requiring acute treatment or hospitalization
- Unable or unwilling to provide consent
- Current severe sedative hypnotic use disorder
- Anuria or on dialysis
- Moderate to severe COVID-19 symptoms with risk of critical illness
- Medical or psychiatric conditions making participation unlikely or requiring higher acute care
- Currently in another interventional clinical trial without a waiver for dual enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404-5015
Terminated
2
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Actively Recruiting
3
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
4
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
5
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
6
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, United States, 06516-2770
Actively Recruiting
7
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
Active, Not Recruiting
8
Wilmington VA Medical Center, Wilmington, DE
Wilmington, Delaware, United States, 19805-4917
Actively Recruiting
9
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744-0000
Actively Recruiting
10
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
11
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Terminated
12
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Terminated
13
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106
Terminated
14
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States, 45428
Actively Recruiting
15
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
16
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Terminated
17
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States, 02908-4734
Terminated
18
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
19
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
Actively Recruiting
20
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States, 05001-3833
Terminated
21
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, United States, 23667
Actively Recruiting
22
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States, 24153-6404
Actively Recruiting
23
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
24
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, United States, 25704-9300
Not Yet Recruiting
25
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-0001
Actively Recruiting
Research Team
A
Avron Spiro, PhD MS
CONTACT
M
Melynn Nuite, RN BS CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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