Standard Versus High Dose ED-Initiated Buprenorphine Induction

Официальное название

ED-Initiated Standard Versus High Dose Buprenorphine Induction

Обзор

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Подробное описание

This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.

Вмешательства

• Препарат Buprenorphine
  All patients will receive 3 pills and will be observed for 2 hours post-study medication administration with repeated COWS at approximately hours 1 and 2. All participants will be given a referral for ongoing MOUD and will be discharged with a prescription for 16 mg daily of buprenorphine daily.

Первичные конечные точки

• Engagement in Treatment (10) [Срок оценки: Within 10 days after study randomization]

Вторичные конечные точки (4)

• Craving [Срок оценки: Measured daily for 10 days post randomization]
• Withdrawal [Срок оценки: Measured daily for 10 days post randomization]
• Substance Use [Срок оценки: Measured daily for 10 days post randomization]
• Engagement in Treatment (30) [Срок оценки: Within 30 days after randomization]

Критерии участия

Критерии включения

All patients enrolled into the study must:

• Be 18-65 years of age.
• Be treated in the ED during study screening hours.
• Meet DSM-5 diagnostic criteria for moderate to severe OUD.
• Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
• Have a urine toxicology test that is positive for opioids.
• Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Критерии исключения

All patients enrolled into the study must not:

• Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
• Have a known hypersensitivity reaction to buprenorphine/naloxone
• Be actively suicidal or severely cognitively impaired precluding informed consent.
• Require ongoing prescription for opioid analgesics.
• Have a physical exam or reported history consistent with severe liver failure
• Have a positive urine test for methadone and reported use in the past 72 hours
• Be a prisoner or in police custody at the time of index ED visit.
• 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 prior enrollment in the current study.
• Receiving MOUD treatment within the past 7 days.
• Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
• Have a respiratory rate <8 or oxygen saturation <93%
• Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Highland Hospital — Oakland
• San Leandro Hospital — San Leandro
• Maine Medical Center — Portland
• Cooper University Hospital — Camden
• University of Utah Hospital — Salt Lake City

Публикации

• Hawk K, Herring A, Chawarski M, Anderson ES, Baumann M, Dorey A, Holtyn AF, Jones C, Martel S, Owens P, Kmiecik K, Strout TD, Taillac P, Lofwall M, Walsh SL, D'Onofrio G. Emergency Department-initiated standard versus high-dose buprenorphine induction (ENVISION): a randomised clinical trial protocol. BMJ Open. 2026 Jun 3;16(6):e113762. doi: 10.1136/bmjopen-2025-113762. PMID 42236100

Идентификаторы

NCT: NCT06494904 · UG1DA015831 · UG1DA015831

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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