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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 4, 2020

Keywords

ClinConnect Summary

This clinical trial, called VA-BRAVE, is examining two different ways to treat opioid use disorder (OUD) in veterans: a daily oral form of buprenorphine that dissolves under the tongue, and a long-acting injectable form that is given as a shot in the belly area. The goal is to see which method is better at helping veterans stick with their treatment and stay off opioids over a period of 28 days. The study will involve 952 veterans and will be conducted over three years, with participants being followed for a full year after starting treatment. Along with the main focus, researchers will also look at other important factors, like the impact on quality of life, mental health, and any substance use issues.

To be eligible for this trial, veterans should have used opioids recently, be seeking treatment for OUD, and be willing to try a specific type of therapy. However, individuals under 18, those who are pregnant or breastfeeding, and those with certain medical or mental health issues may not qualify. Participants will be randomly assigned to receive either the oral or injectable form of buprenorphine and will be monitored throughout the study for various outcomes. This research aims to help improve treatment options for veterans dealing with opioid addiction.

Gender

ALL

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 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
• • 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.