Trial Search Results

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

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 16-24 mg (standard of care). This is an open-label, randomized, controlled trial including 900 Veterans with opioid use disorder (OUD) recruited over 3 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 C (HCV) testing results and risk behaviors, incarceration, quality of life, psychiatric symptoms of depression and posttraumatic stress disorder, housing status, and cost-effectiveness.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

VA Office of Research and Development

Stanford Investigator(s):

Intervention(s):

  • Drug: Sublingual buprenorphine with naloxone
  • Drug: Injectable subcutaneous buprenorphine

Phase:

Phase 4

Eligibility


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

   - Meets 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

   - Has been taking a form of prescribed Medication-assisted treatment (MAT) continuously
   >30 days prior to time of consent

   - Has a history of significant adverse effects from buprenorphine and/or naloxone

   - Has experienced recent suicidal ideation that requires hospitalization.

   - Is unwilling or unable to provide consent

   - Meets criteria for sedative hypnotic use disorder based on the MINI (Sedative Hypnotic
   Use Disorder)

   - Has pending felony charges

   - Is determined unsuitable for study participation based on the clinical judgement of
   the LSI or Co-I given results of a CIWA-Ar, physical exam, Liver function tests,
   kidney function tests, and CBC

   - Is determined unsuitable for study participation based on observed prolonged QTc
   interval on an electrocardiogram (EKG)

   - Has any other medical, psychiatric, behavioral, or logistical condition which, in the
   judgement of the LSI or Co-I, makes it unlikely the participant 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michael Ostacher, MD
650-849-0494
Recruiting