Status:
RECRUITING
A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
Lead Sponsor:
VA Office of Research and Development
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sustai...
Detailed Description
CSP2014 is the first direct long-term comparison of monthly injectable versus daily SL buprenorphine. In addition to its impact on the care of Veterans, the results of VA-BRAVE will provide critical d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
952 Patients enrolled
Trial Details
Trial ID
NCT04375033
Start Date
November 3 2020
End Date
May 31 2029
Last Update
October 24 2025
Active Locations (25)
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1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404-5015
2
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
3
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
4
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207