Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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.

Official Title

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

Details

Keywords

Opioid Use Disorder, Buprenorphine, Veterans, Clinical Trial, Opioid Abstinence, Retention in Care, Pharmacotherapy, Opioid-Related Disorders, Substance-Related Disorders, Naloxone, Sublingual buprenorphine with naloxone, Injectable subcutaneous buprenorphine

Eligibility

Locations

  • San Francisco VA Medical Center, San Francisco, CA accepting new patients
    San Francisco California 94121-1563 United States
  • VA Long Beach Healthcare System, Long Beach, CA accepting new patients
    Long Beach California 90822 United States
  • VA Palo Alto Health Care System, Palo Alto, CA accepting new patients
    Palo Alto California 94304-1207 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04375033
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 952 study participants
Last Updated