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Sponsor: VA Office of Research and Development
Conditions: Opioid Use Disorder
Interventions: Sublingual buprenorphine with naloxone, Injectable subcutaneous buprenorphine
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Tuscaloosa, Alabama, United States
- Phoenix, Arizona, United States
- Long Beach, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- West Haven, Connecticut, United States
- West Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Bay Pines, Florida, United States
- Gainesville, Florida, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Cleveland, Ohio, United States
- Dayton, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- White River Junction, Vermont, United States
- Hampton, Virginia, United States
- Salem, Virginia, United States
- Seattle, Washington, United States
- Huntington, West Virginia, United States
- Milwaukee, Wisconsin, United States