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A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Recruiting
I'm InterestedTrial ID: NCT04375033
Purpose
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.
Official Title
CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)
Stanford Investigator(s)
Eligibility
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 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
Exclusion Criteria:
- 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
Intervention(s):
drug: Sublingual buprenorphine with naloxone
drug: Injectable subcutaneous buprenorphine
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michael Ostacher, MD
650-849-0494