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Befejeződött2. fázis

Emergency Department-Initiated Buprenorphine Validation Network Trial

A legfontosabb adatok

Ki végzi
Yale University
Hol
Albuquerque, Atlanta, Baltimore, Camden, Charleston, Chicago, Dallas, Detroit, Durham, Lebanon, Martinsburg, Miami, Minneapolis, Nashville, New Haven, New York, Oakland, Philadelphia, Pittsburgh, Portland, Providence, Salt Lake City, San Leandro, Seattle, St Louis, Syracuse, Tampa és Winston-Salem (Egyesült Államok)Mind a 35 helyszín megnézése
Azonosító
Állapot
Befejeződött
Fázis
2. fázis
Résztvevők
2000 fő vett részt
Kezdés
2020. júl. 8.
Befejezés
2024. dec. 6.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • CAM2038
  • Buprenorphine Sublingual Product
A regiszteradat frissítve
2025. január 10.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 36 feltétel megnézéseKevesebb

Ki vehet részt

  • Be 18 years or older
  • Treated in the ED during study screening hours
  • Meet DSM-5 (Diagnostic and Statistical Manual) diagnostic criteria for moderate to severe OUD
  • Have a COWS score of > or equal to 4
  • Have a urine toxicology test that is positive for opioids (opiates, oxycodone, buprenorphine). Patients with urines that are only positive for fentanyl will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD
  • Able to speak English sufficiently to understand the study the study procedures and provide written informed consent to participate in the study. (Exception may be made if sites with large population of Spanish speaking patients are accepted for participation in the study and study materials are translated into Spanish. Translated study materials will be reviewed and approved by the Institutional Review Board) IRB of record prior to use.)
  • Be 18 years or older
  • Treated in the ED during study screening hours
  • Meet DSM-5 diagnostic criteria for moderate to severe opioid use disorder
  • Have a COWS <8
  • Have a urine toxicology test that is positive for opioids (opiates, oxycodone, or buprenorphine). Patients with urines that are only positive for fentanyl on the point of care test strip will be eligible if their clinical history and physical exam are consistent with opioid use and they meet DSM-5 criteria for moderate to severe OUD
  • Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study

Ki nem vehet részt

  • Opioid administration (excluding BUP) at the index ED visit, prior to enrollment, and COWS remains < 8 during ED stay
  • Be currently (anytime within the past 14 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction who are not receiving MOUD are eligible
  • Have prior enrollment in the current study component; Ancillary Component:
  • Have a medical or psychiatric condition that requires hospitalization at the index ED visit, prior to enrollment
  • Be currently (anytime within the past 7 days) enrolled in formal addiction treatment, including by court order. Patients enrolled in formal addiction treatment but are not receiving MOUD are eligible
  • Have prior enrollment in the current study
  • Have a medical or psychiatric condition that requires hospitalization
  • Require continued prescription opioids for a pain condition
  • Require continued prescription opioids for a pain condition
  • Have urine toxicology test that is positive for methadone
  • Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
  • Be actively suicidal or severely cognitively impaired precluding informed consent
  • Present from an extended care facility (e.g., skilled nursing facility)
  • Be a prisoner or in police custody at the time of index ED visit
  • Be unable to provide reliable locator information including 2 contact numbers in addition to their own
  • Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
  • Have a urine toxicology test that is positive for methadone
  • Be pregnant as determined by human chorionic gonadotropin (hCG) testing at the index ED visit
  • Be actively suicidal or severely cognitively impaired precluding informed consent
  • Present from an extended care facility (e.g., skilled nursing facility)
  • Be a prisoner or in police custody at the time of index ED visit
  • Be unable to provide reliable locator information including 2 contact numbers in addition to their own
  • Be unwilling to follow study procedures (e.g., unwilling to provide permission to answer daily assessments until day 7)

Egyéb feltételek

  • RCT Component:

Helyszínek itt: Egyesült Államok

  • Presybterian Hospital, Albuquerque, NMAlbuquerque, Egyesült Államok
  • University of New Mexico HospitalAlbuquerque, Egyesült Államok
  • Grady Memorial HospitalAtlanta, Egyesült Államok
  • Johns Hopkins HospitalBaltimore, Egyesült Államok
  • Cooper University HospitalCamden, Egyesült Államok
  • Medical University of South CarolinaCharleston, Egyesült Államok
  • Northwestern Memorial HospitalChicago, Egyesült Államok
  • University of Chicago MedicineChicago, Egyesült Államok
  • Parkland Memorial HospitalDallas, Egyesült Államok
  • Detroit Receiving HospitalDetroit, Egyesült Államok
  • Henry Ford HospitalDetroit, Egyesült Államok
  • Duke UniversityDurham, Egyesült Államok
  • Dartmouth Hitchcock Medical CenterLebanon, Egyesült Államok
  • West Virginia University - Berkeley Medical CenterMartinsburg, Egyesült Államok
  • Jackson Memorial HospitalMiami, Egyesült Államok
  • Hennepin County Medical CenterMinneapolis, Egyesült Államok
  • Vanderbilt University Medical CenterNashville, Egyesült Államok
  • Yale New Haven Health (Yale New Haven Hospital)New Haven, Egyesült Államok
  • Bellevue HospitalNew York, Egyesült Államok
  • Columbia University Irving Medical Center- NY PresbyterianNew York, Egyesült Államok
  • Icahn School of MedicineNew York, Egyesült Államok
  • Weill Cornell Medical CollegeNew York, Egyesült Államok
  • Highland HospitalOakland, Egyesült Államok
  • Pennsylvania Presbyterian Medical Center/Hospital of UPENNPhiladelphia, Egyesült Államok
  • Temple University Hospital - Episcopal CampusPhiladelphia, Egyesült Államok
  • UPMC-Mercy HospitalPittsburgh, Egyesült Államok
  • Maine Medical CenterPortland, Egyesült Államok
  • Rhode Island Hospital/The Miriam HospitalProvidence, Egyesült Államok
  • University of Utah HospitalSalt Lake City, Egyesült Államok
  • San Leandro HospitalSan Leandro, Egyesült Államok
  • University of Washington Medical Center- Harborview/MontlakeSeattle, Egyesült Államok
  • Barnes-Jewish HospitalSt Louis, Egyesült Államok
  • Upstate Medical UniversitySyracuse, Egyesült Államok
  • Tampa General HospitalTampa, Egyesült Államok
  • Wake Forest School of MedicineWinston-Salem, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

This study will (1) recruit, train and provide resources to approximately 30 Emergency Department (ED) sites throughout the U.S. using implementation facilitation strategies to provide ED-initiated buprenorphine (BUP) for patients presenting with opioid use disorder (OUD) who are not receiving medications for opioid use disorder (MOUD). Once implementation is adequately achieved, the sites will (2) conduct a randomized controlled trial (RCT) to compare the effectiveness of sublingual buprenorphine (SL-BUP) versus extended-release buprenorphine (XR-BUP) on ED patients' engagement in formal addiction treatment 7-days after their ED visit. In addition, in an ancillary component of the study, the investigators will (3) assess the use of XR-BUP in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores < 8 in a case series to potentially expand the eligibility of patients in the larger RCT to those presenting with little to no opioid withdrawal symptoms. Finally, the investigators will (4) develop and validate ED electronic health record (EHR) opioid-related phenotypes, both of which will inform the main RCT.

A vizsgálat 2 csoportja

  • XR-BUPA vizsgált kezelés

    Injectable buprenorphine

    Kezelés: CAM2038

  • Standard SL-BUPMár használt kezelés, összehasonlításként

    Sublingual buprenorphine

    Kezelés: Buprenorphine Sublingual Product

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Publikációk
A regiszteradat frissítve
2025. január 10.