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

Description

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 16-32 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.

Conditions

Opioid Use Disorder

Talk to us

Study Overview

On this page

Study Details

Study overview

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 16-32 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.

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

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

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa, Alabama, United States, 35404-5015

Phoenix

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona, United States, 85012

Long Beach

VA Long Beach Healthcare System, Long Beach, CA, Long Beach, California, United States, 90822

Palo Alto

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States, 94304-1207

San Francisco

San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States, 94121-1563

West Haven

CERC (VISN1, West Haven, CT), West Haven, Connecticut, United States, 06516-2770

West Haven

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States, 06516-2770

Wilmington

Wilmington VA Medical Center, Wilmington, DE, Wilmington, Delaware, United States, 19805-4917

Bay Pines

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines, Florida, United States, 33744-0000

Gainesville

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, United States, 32608-1135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * Failure to reach maintenance dose of 8mg - 32mg SL-BUP/NLX in 45 days or less (must have taken 3 consecutive days of maintenance dose immediately before randomization).
  • * 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Ismene L. Petrakis, MD, STUDY_CHAIR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Sandra Ann Springer, MD, STUDY_CHAIR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Record Dates

2029-05-31