NCT04375033 A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
| NCT ID | NCT04375033 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 952 participants |
| Start Date | 2020-11-03 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 952 participants in total. It began in 2020-11-03 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous 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 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.
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 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 4mg - 32mg SL-BUP/NLX in 45 days or less. * 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.
Contact & Investigator
Ismene L. Petrakis, MD
STUDY CHAIR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Frequently Asked Questions
Who can join the NCT04375033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04375033 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04375033 currently recruiting?
Yes, NCT04375033 is actively recruiting participants. Contact the research team at avron.spiro@va.gov for enrollment information.
Where is the NCT04375033 trial being conducted?
This trial is being conducted at Tuscaloosa, United States, Phoenix, United States, Long Beach, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT04375033 clinical trial?
NCT04375033 is sponsored by VA Office of Research and Development. The principal investigator is Ismene L. Petrakis, MD at VA Connecticut Healthcare System West Haven Campus, West Haven, CT. The trial plans to enroll 952 participants.