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Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments

A legfontosabb adatok

Ki végzi
University of British Columbia
Hol
Kanada6 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Fázis
2/3. fázis
Résztvevők
658 fő, tervezett
Kezdés
2021. júl. 23.
Várható befejezés
2028. jún.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Buprenorphine/naloxone
A regiszteradat frissítve
2026. szeptember 24.

Ki vehet részt

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

A regiszter feltételei, szó szerint

Mind a 23 feltétel megnézéseKevesebb

Ki vehet részt

  • We will include ED patients ≥18 years of age with opioid use disorder who are being discharged from the ED. We will define opioid use disorder as non-medical opioid use in the previous 30 days and a positive score for opioid dependency based on the validated Rapid Opioid Dependence Screen (RODS)
  • All patients will also be assessed by the treating physician or degree of clinical opioid withdrawal, based on the clinical opiate withdrawal scale (COWS) score. Patients will be eligible for the take-home study interventions if they have a COWS score <=12, as a score greater than 12 would mean the patient is a candidate for standard buprenorphine induction in the ED at that moment in time, and would therefore not be eligible for outpatient study interventions

Ki nem vehet részt

  • Actively receiving OAT, defined as having filled a prescription for one of the following medications in the 5 days prior to ED presentation: buprenorphine/naloxone, methadone, sustained release morphine, injectable hydromorphone, injectable diacetylmorphine
  • Prior enrollment in the study
  • Suspected surgical abdomen (e.g., acute appendicitis or pancreatitis)
  • Concurrent withdrawal or intoxication from sedatives (e.g., alcohol, benzodiazepines)
  • Active prescription for sedative medications (e.g., benzodiazepines, opioids)
  • Use of monoamine oxidase inhibitors within the past 14 days
  • Concerns that the patient is unable to safely store medications
  • Pregnancy (we will obtain a point-of-care urine pregnancy test on all women of child-bearing age prior to enrollment)
  • Are taking opioids for cancer or palliative-care related indications
  • Known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type)
  • Severe respiratory insufficiency
  • Allergy to buprenorphine/naloxone
  • Active withdrawal at time of ED assessment (Clinical Opiate Withdrawal Score [COWS] >12)
  • Admitted to hospital
  • Severe communication barriers that inhibit patients' understanding of study procedures and interventions
  • Are deemed unsafe to approach by ED providers
  • Incarceration
  • Not a resident of the province in which they are seeking care (BC or Alberta)
  • Severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury
  • Complicating patient factors that make home inductions from the ED unsafe and/or that require expert consultation for consideration of induction in an observed setting; These factors include:
  • Severe respiratory or liver dysfunction

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A vizsgálatról

Mit akar kideríteni a vizsgálat

This is a multi-centre, open-label RCT at four Emergency Departments (EDs) in British Columbia and Alberta. The purpose of the current study is to compare the effectiveness of buprenorphine/naloxone microdosing and standard dosing take-home induction regimens at enabling patients to successfully complete the induction regimen, and at retaining patients on opioid agonist therapy.

A teljes eredeti leírásKevesebb

We will randomize our enrolled patients to receive take-home microdosing or standard dosing packages of buprenorphine/naloxone. For the microdosing arm, patients immediately start taking low doses that increase to effective levels without requiring them to go into withdrawal.

We hypothesize that ED patients provided buprenorphine/naloxone microdosing packages will be more likely to successfully complete the induction period compare to patients provided standard dosing packages. We furthermore hypothesize that those provided microdosing will be more likely to be retained in opioid agonist therapy, and will experience lower overdose, mortality, and healthcare utilization subsequent to their ED visit.

A vizsgálat 2 csoportja

  • Buprenorphine/naloxone MicrodosingMár használt kezelés, összehasonlításként

    Participants with Opioid use disorder will receive a Buprenorphine/naloxone microdosing package from the ED. This will consist of a five-day take-home packages with gradually increasing doses of 2mg/0.5mg buprenorphine/naloxone tablet employing a four times daily dosing schedule over five days. Day 1: Buprenorphine 0.5 mg-naloxone 0.125 mg SL\* QID\*\* (One quarter tablet), Day 2: Buprenorphine 1 mg-naloxone 0.25 mg SL QID (One half tablet), Day 3: Buprenorphine 2 mg-naloxone 0.5 mg SL QID (1 tablet), Day 4: Buprenorphine 3 mg-naloxone 0.75 mg SL QID (1.5 tablets) Day 5: Buprenorphine 16 mg-naloxone 4 mg SL once daily (8 tablets). \*SL: Sublingual \*\* QID: four times daily

    Kezelés: Buprenorphine/naloxone

  • Buprenorphine/naloxone Standard DosingMár használt kezelés, összehasonlításként

    The control intervention will be provision of a buprenorphine/naloxone standard dosing package from the ED. This will consist of a five day package with a commonly accepted standard dosing regimen aiming to achieve a therapeutic buprenorphine/naloxone dose within 24 hours of initiation. Standard dosing packages are currently available in EDs in BC and Alberta as standard of care. Day 1: Buprenorphine 2 mg-naloxone 0.5 mg SL q1h prn to a maximum of 6 tablets in the first 24 hours (1 tablet), Day 2: Buprenorphine 12 mg-naloxone 3 mg SL once daily (6 tablets), Day 3: Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets), Day 4:Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets). Day 5:Buprenorphine 16 mg-naloxone 3 mg SL once daily (8 tablets).

    Kezelés: Buprenorphine/naloxone

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Evaluating Microdosing in Emergency Departments: A Randomized Controlled Trial Comparing the Effectiveness of Buprenorphine/Naloxone Microdosing vs. Standard Dosing (EMED Study)
A regiszteradat frissítve
2026. szeptember 24.