🔎 Trials Near Me

Home › Opioid Overdose › NCT04375033

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

RecruitingPhase 4

CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: VA Office of Research and Development · Participants: 952 · Started: Nov 3, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04375033

Locations in the U.S.

ArizonaPhoenix VA Health Care System, Phoenix, AZ, Phoenix
CaliforniaVA Long Beach Healthcare System, Long Beach, CA, Long Beach
VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto
San Francisco VA Medical Center, San Francisco, CA, San Francisco
ConnecticutCERC (VISN1, West Haven, CT), West Haven
DelawareWilmington VA Medical Center, Wilmington, DE, Wilmington
FloridaBay Pines VA Healthcare System, Pay Pines, FL, Bay Pines
North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville
OhioDayton VA Medical Center, Dayton, OH, Dayton
PennsylvaniaPhiladelphia MultiService Center, Philadelphia, PA, Philadelphia
TexasVA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas
UtahVA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City
VirginiaHampton VA Medical Center, Hampton, VA, Hampton
Salem VA Medical Center, Salem, VA, Salem
WashingtonVA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle
West VirginiaHuntington VA Medical Center, Huntington, WV, Huntington
WisconsinClement J. Zablocki VA Medical Center, Milwaukee, WI, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.