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

• Status: Recruiting
• Trial end date: 2024-11-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Buprenorphine; Naloxone

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

• 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