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Comparing oral and injectable buprenorphine for treating opioid use disorder in veterans

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

PHASE4 · VA Office of Research and Development · NCT04375033

This study is testing whether a long-acting injectable form of buprenorphine helps veterans with opioid use disorder stay in treatment and stay off opioids better than the usual daily pill form.

Quick facts

PhasePHASE4
Study typeInterventional
Enrollment952 (estimated)
Ages18 Years and up
SexAll
SponsorVA Office of Research and Development (fed)
Locations25 sites (Tuscaloosa, Alabama and 24 other locations)
Trial IDNCT04375033 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a long-acting injectable formulation of buprenorphine compared to the standard daily sublingual formulation in retaining veterans with opioid use disorder in treatment and sustaining opioid abstinence. It is an open-label, randomized, controlled trial involving 952 veterans over a 52-week period, with multiple study visits and a focus on various secondary outcomes such as substance use, overdose risk, and quality of life. Participants will be inducted on daily sublingual buprenorphine before being randomized to receive either the injectable or sublingual formulation.

Who should consider this trial

Good fit: Ideal candidates are veterans aged 18 and older diagnosed with moderate to severe opioid use disorder who are entering a new episode of care.

Not a fit: Patients who are not veterans, under 18 years of age, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment retention and opioid abstinence rates among veterans with opioid use disorder.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this is the first direct long-term comparison of these two formulations in a veteran population.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tuscaloosa, Alabama and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Opioid Use Disorder, Buprenorphine, Veterans, Clinical Trial, Opioid Abstinence, Retention in Care, Pharmacotherapy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.