A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder
A legfontosabb adatok
- Ki végzi
- VA Office of Research and Development
- Hol
- Bay Pines, Boston, Cleveland, Dallas, Dayton, Gainesville, Hampton, Huntington, Long Beach, Milwaukee, Minneapolis, Palo Alto, Philadelphia, Phoenix, Pittsburgh, Providence, Salem, Salt Lake City, San Francisco, Seattle, Tuscaloosa, West Haven, White River Junction és Wilmington (Egyesült Államok)Mind a 25 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Fázis
- 4. fázis
- Résztvevők
- 952 fő, tervezett
- Kezdés
- 2020. nov. 3.
- Várható befejezés
- 2029. máj. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Sublingual buprenorphine with naloxone
- Injectable subcutaneous buprenorphine
- A regiszteradat frissítve
- 2026. szeptember 10.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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 Medications for Opioid Use Disorder (MOUD) via clinical induction on SL-BUP/NLX
- Meets DSM-5 criteria for moderate to severe opioid use disorder (OUD) based on the Mini-International Neuropsychiatric Interview
- Referred to/seeking treatment for OUD and willing to accept "partial-agonist-based" therapy
Ki nem vehet részt
- Taking a form of prescribed maintenance Medications for Opioid Use Disorder (MOUD), e.g., methadone, buprenorphine or XR-NTX) continuously >45 days prior to randomization
- 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 4 milligrams (mg) - 32mg SL-BUP/NLX in 45 days or less
- Has a history of significant adverse effects from buprenorphine and/or naloxone
- Meets criteria for current (past month) DSM-5 severe sedative hypnotic use disorder based on the MINI Sedative, Hypnotic, or Anxiolytic Use Disorder (SHUD) module
- 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
- 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
- Anuria and/or dialysis
- Is actively participating in an interventional clinical trial for which a waiver of dual-enrollment with CSP #2014 has not been obtained
Helyszínek itt: Egyesült Államok
- Bay Pines VA Healthcare System, Pay Pines, FLBay Pines, Egyesült ÁllamokContact: Maha Lahoud-Bladykas, MDRésztvevőt keres
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABoston, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- Louis Stokes VA Medical Center, Cleveland, OHCleveland, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallas, Egyesült ÁllamokContact: Ashley Woolbert, MDRésztvevőt keres
- Dayton VA Medical Center, Dayton, OHDayton, Egyesült ÁllamokContact: Bret Becker, MDRésztvevőt keres
- North Florida/South Georgia Veterans Health System, Gainesville, FLGainesville, Egyesült ÁllamokContact: Leonardo Rodriguez, MDRésztvevőt keres
- Hampton VA Medical Center, Hampton, VAHampton, Egyesült ÁllamokContact: Ajay Manhapra, MDRésztvevőt keres
- Huntington VA Medical Center, Huntington, WVHuntington, Egyesült ÁllamokContact: Jack Wang, MDRésztvevőt keres
- VA Long Beach Healthcare System, Long Beach, CALong Beach, Egyesült ÁllamokContact: Ricardo Restrepo-Guzman, MDRésztvevőt keres
- Clement J. Zablocki VA Medical Center, Milwaukee, WIMilwaukee, Egyesült ÁllamokContact: Matthew Stohs, MDRésztvevőt keres
- Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- VA Palo Alto Health Care System, Palo Alto, CAPalo Alto, Egyesült ÁllamokContact: Michael Ostacher, MDRésztvevőt keres
- Philadelphia MultiService Center, Philadelphia, PAPhiladelphia, Egyesült ÁllamokContact: Kyle Kampman, MDRésztvevőt keres
- Phoenix VA Health Care System, Phoenix, AZPhoenix, Egyesült ÁllamokContact: Kerri Grover, BSNRésztvevőt keres
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburgh, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- Providence VA Medical Center, Providence, RIProvidence, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- Salem VA Medical Center, Salem, VASalem, Egyesült ÁllamokContact: Anjali Varma, MDRésztvevőt keres
- VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, Egyesült ÁllamokContact: Adam Gordon, MDRésztvevőt keres
- San Francisco VA Medical Center, San Francisco, CASan Francisco, Egyesült ÁllamokContact: Steven Batki, MDRésztvevőt keres
- VA Puget Sound Health Care System Seattle Division, Seattle, WASeattle, Egyesült ÁllamokContact: Justin Stamschror, MDRésztvevőt keres
- Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosa, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- CERC (VISN1, West Haven, CT)West Haven, Egyesült ÁllamokContact: Brian Fuehrlein, MDRésztvevőt keres
- VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest Haven, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- White River Junction VA Medical Center, White River Junction, VTWhite River Junction, Egyesült ÁllamokContact: Avron Spiro, PhD MSNo longer taking part
- Wilmington VA Medical Center, Wilmington, DEWilmington, Egyesült ÁllamokContact: Daniel J LacheRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
VA-BRAVE will determine whether a 28-day long-acting injectable sub-cutaneous formulation of buprenorphine at a target dose of 300 milligrams (mg) 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 4-32 mg (standard of care). This is an open-label, randomized, controlled trial including 952 Veterans with opioid use disorder (OUD) recruited over 7 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 B (HBV) and C (HCV) testing results and risk behaviors, incarceration, quality of life, psychiatric symptoms of depression and posttraumatic stress disorder, housing status, dental health and utilization, and cost-effectiveness.
A vizsgálat 2 csoportja
- Sublingual ArmA vizsgált kezelés
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.
Kezelés: Sublingual buprenorphine with naloxone
- Injectable ArmA vizsgált kezelés
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.
Kezelés: Injectable subcutaneous buprenorphine
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- CSP #2014 - Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE)
- Publikációk
- A regiszteradat frissítve
- 2026. szeptember 10.