RECRUITING Phase 4 ClinicalTrials.gov

A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT04375033

Registry updated: 2026-09-10

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Description

VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous formulation of buprenorphine at a target dose of 300 milligrams (mg) 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.

Interventions

Sublingual buprenorphine with naloxone (Drug)
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 (Drug)
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.

Eligibility criteria

Inclusion Criteria: * 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 Medications for Opioid Use Disorder (MOUD) via clinical induction on SL-BUP/NLX * Meets DSM-5 criteria for moderate to severe opioid use disorder (OUD) based on the Mini-International Neuropsychiatric Interview * Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy Exclusion Criteria: * 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 4 milligrams (mg) - 32mg SL-BUP/NLX in 45 days or less * Taking a form of prescribed maintenance Medications for Opioid Use Disorder (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 Sedative, Hypnotic, or Anxiolytic Use Disorder (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

Conditions

Opioid Use Disorder

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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