A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
NCT ID: NCT04375033
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
952 participants
INTERVENTIONAL
2020-11-03
2029-05-31
Brief Summary
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Detailed Description
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The CSP2014 study population is Veterans aged 18 years diagnosed with moderate to severe opioid use disorder (OUD) by Diagnostic and Statistical Manual (DSM)-5th edition criteria. Veterans must be entering a new episode of opioid use disorder care prior to study start.
There are two primary outcomes that address key Veterans Health Administration (VHA) clinical issues related to opioid use disorder treatment. The first is retention on protocol-directed medication treatment (sublingual or injectable sub-cutaneous buprenorphine). The second primary outcome is opioid abstinence using the systematic Timeline Followback method of self-report and corresponding urine toxicology screens.
VA-BRAVE includes a 52-week intervention with multiple study visits and up to a 10-year passive follow-up for the duration of the study. Participants are inducted on daily SL buprenorphine using SAMHSA guidelines and dosed upward for a target dose of 4-32 mg for 1 day (should not exceed 45 days). Once target dose reached, participants are randomized 1:1 and assigned to receive at each 28-day research visit either: 1) a 28-day take-home supply of SL buprenorphine, prescribed at the clinically determined dose, or 2) injectable sub-cutaneous buprenorphine administered in the clinic (target dose = 300mg; 100mg dose may be used for those who cannot tolerate 300mg). Participants also receive Medication Management intervention at these visits.
Study visits for all participants occur at Weeks 1, 2, 3 and 4 post-randomization, and biweekly thereafter through Week 52. Self-reported abstinence and urine toxicology screens are obtained at biweekly visits. Following one year of active follow-up, administrative data will be used to follow participants for up to 10 years for early enrollees and up to 7 years for late enrollees. The recruitment expectation is 7 new participants per study year per study site. There will be up to 20 participating VA Medical Center sites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sublingual Arm
The sublingual buprenorphine contains naloxone in a ratio of 4:1 and will be prescribed. Consistent with the SAMHSA guidelines, before SL-BUP/NLX is prescribed, participants will be evaluated for recent (within 24 hours) drug use and associated symptoms.
The randomization dose will be determined based on the maintenance dose identified during the induction period, with a target dose of 4-32mg that is standard practice. While the target dose is 4-32mg, occasionally patients may prefer lower doses. SL-BUP/NLX will be prescribed at the randomization visit (28-day supply), then every 4 weeks through week 48.
Sublingual buprenorphine with naloxone
The combination SL-containing buprenorphine contains naloxone in a ratio of 4:1 buprenorphine:naloxone. Participants will be given a 28-prescription at each 28-day visit through Week 48.
Injectable Arm
Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously at each 28-day visit. The target dose is 300mg, there is the option to use 100mg dose. The final study dose of injectable buprenorphine will be given at Week 48.
Injectable subcutaneous buprenorphine
Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously at each 28-day visit through Week 48.
Interventions
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Sublingual buprenorphine with naloxone
The combination SL-containing buprenorphine contains naloxone in a ratio of 4:1 buprenorphine:naloxone. Participants will be given a 28-prescription at each 28-day visit through Week 48.
Injectable subcutaneous buprenorphine
Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously at each 28-day visit through Week 48.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Ismene L. Petrakis, MD
Role: STUDY_CHAIR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Sandra Ann Springer, MD
Role: STUDY_CHAIR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Locations
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Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
CERC (VISN1, West Haven, CT)
West Haven, Connecticut, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Wilmington VA Medical Center, Wilmington, DE
Wilmington, Delaware, United States
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
Dayton VA Medical Center, Dayton, OH
Dayton, Ohio, United States
Philadelphia MultiService Center, Philadelphia, PA
Philadelphia, Pennsylvania, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, United States
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, United States
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Petrakis I, Springer SA, Davis C, Ralevski E, Gu L, Lew R, Hermos J, Nuite M, Gordon AJ, Kosten TR, Nunes EV, Rosenheck R, Saxon AJ, Swift R, Goldberg A, Ringer R, Ferguson R. Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans. Addict Sci Clin Pract. 2022 Jan 31;17(1):6. doi: 10.1186/s13722-022-00286-6.
Other Identifiers
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2014
Identifier Type: -
Identifier Source: org_study_id
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