A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Trial ID or NCT#
VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous (in the belly area) 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 16-24 mg (standard of care). This is an open-label, randomized, controlled trial including 952 Veterans with opioid use disorder (OUD) recruited over 3 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.
CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)
- - 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 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
- - 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 - Taking a form of prescribed maintenance MOUD (e.g., methadone, buprenorphine or XR-NTX) continuously >30 days prior to consent. - 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 - Is determined unsuitable for study participation based on the clinical judgement of the LSI or Co-I given results of a CIWA-Ar, physical exam, and/or liver or kidney function tests and/or blood tests - Has any other medical, psychiatric, behavioral, or logistical condition which, in the judgement of the LSI or Co-I, makes it unlikely the participant 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
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Michael Ostacher, MD