Your session is about to expire
← Back to Search
Buprenorphine Forms for Opioid Use Disorder (VA-BRAVE Trial)
VA-BRAVE Trial Summary
This trial will compare two different ways of taking buprenorphine to see if one is better than the other at helping people with opioid addiction.
VA-BRAVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVA-BRAVE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VA-BRAVE Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am a Veteran and under 18 years old.I have been on prescribed medication-assisted treatment for over 30 days.You have recently had thoughts of hurting yourself and needed to go to the hospital for help.I have used opioids in the last 30 days or just before entering a supervised setting.You have a moderate to severe opioid use disorder (OUD) based on a special interview called the Mini-International Neuropsychiatric Interview.I am seeking treatment for opioid use disorder and open to partial-agonist therapy.I have had severe side effects from buprenorphine or naloxone.I am seeking treatment for opioid use disorder and open to partial-agonist therapy.I have used opioids in the last 30 days or before entering a supervised setting.
- Group 1: Sublingual Arm
- Group 2: Injectable Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What health conditions is injectable subcutaneous buprenorphine most frequently prescribed for?
"Subcutaneous buprenorphine is commonly utilized to address opioid dependency, however it may also be beneficial in ameliorating pruritus, pain and septic shock."
How widely distributed is this clinical research throughout North America?
"The Minneapolis VA Health Care System in Minnesota, Dayton VA Medical Center in Ohio, and Hampton VA Medical Centre in Virginia are the three primary sites for this clinical trial. Additionally, there are an additional 18 locations offering enrollment opportunities."
How has the efficacy of injectable subcutaneous buprenorphine been evaluated in other scientific trials?
"Presently, there are 56 Injectable subcutaneous buprenorphine trials in progress with 13 Phase 3 studies. These clinical experiments originate primarily from White River Junction, Vermont but can also be found at 235 other medical sites around the world."
What has the Federal Drug Administration determined about utilizing injectable subcutaneous buprenorphine?
"Data from clinical trials and other sources show that injectable subcutaneous buprenorphine is a safe therapy, thus it has earned an estimated safety rating of 3."
What outcome is this experiment striving to achieve?
"The purpose of this trial, monitored over a period of 52 weeks, is to promote opioid abstinence. Secondary objectives include gauging the intensity of an individual's craving for opioids via a 10-point Likert scale, assessing Post Traumatic Stress Disorder by employing the DSM-5 checklist and determining if any other addictive substances have been consumed using both Timeline Followback self-reporting measures as well as urine toxicology results."
Are there still open opportunities to become participants in this research study?
"Affirmative. The information available on clinicaltrials.gov confirms this investigation is actively seeking participants with an initial posting date of November 3rd 2020, and the last update was June 1st 2022. There are 18 enrolment sites across the US searching for 952 individuals to participate in their trial."
What is the estimated cohort size of participants in this trial?
"952 participants who meet the eligibility criteria are sought for this study. Qualifying patients may join from Minneapolis VA Health Care System, Minneapolis, MN or Dayton VA Medical Center, Dayton, OH in Minnesota and Ohio respectively."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
Share this study with friends
Copy Link
Messenger