Standard versus High Dose ED-Initiated Buprenorphine Induction

标准剂量与高剂量 ED 引发的丁丙诺啡诱导

基本信息

  • 批准号:
    10801950
  • 负责人:
  • 金额:
    $ 128.6万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-03-06 至 2025-02-28
  • 项目状态:
    未结题

项目摘要

Abstract Drug overdoses in the U.S. increased to over 107,000 in the year ending January 2022 including > 80,000 involving opioids, representing a 24% increase from the prior year. Despite improved outcomes and decreased all-cause mortality among individuals with opioid use disorder (OUD) who receive opioid agonist treatment, only 11% of individuals with OUD receive medications for opioid use disorder. Narrowing the treatment gap by expanding access to treatment beyond specialized drug treatment settings is a public health priority, and the Emergency Department (ED), offering access 24 hours, 7 days a week, 365 days a year, is a logical point of intervention. ED patients have a disproportionately high prevalence of OUD, and for many, the ED is the primary or only access point in the healthcare system. There are currently no controlled, prospective studies comparing dosing strategies for buprenorphine induction in the ED. We propose a multisite randomized double-blind, double-dummy, clinical trial of ED patients with moderate to severe OUD (N=360) from 4 geographically diverse EDs to compare Standard ED Dose Induction (SDI; 8 mg) with High Dose Induction (HDI; 24 mg) to evaluate AIM 1: Engagement in continuing OUD treatment at 10 days and AIM 2: Differences in outcomes of craving, tolerability, withdrawal symptoms, and use of illicit drugs. We hypothesize that patients assigned to the HDI group will be more likely to be engaged in OUD treatment at 10 days post ED enrollment (primary outcome), and will describe less craving, less withdrawal symptoms and less use of illicit drugs during the 10 days post ED buprenorphine induction. Additional outcomes will be the development of ED protocols, and evaluation of safety, feasibility, and acceptability. The primary outcome of engagement in treatment at 10 days as well as treatment at day 30 will be verified by the treating clinician. Assessment of craving, withdrawal symptoms and use of illicit drugs will be obtained by daily Qualtrics phone surveys. The planned study sample and the proposed analytical methods will allow for additional meaningful exploratory evaluations of potential differential effects of gender, race, ethnicity, housing instability, insurance status, and use of fentanyl, and other polysubstance use such as stimulants, sedatives, and alcohol. An accelerated achieves potentially treatment induction process that therapeutic buprenorphine levels in less than 3-4 hours compared to the typical 2-3 days could increase safety during the crucial gap between ED discharge and engagement in continuation by limiting illicit opioid use and encouraging follow up visits for OUD treatment.
摘要

项目成果

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Gail D'Onofrio其他文献

Gail D'Onofrio的其他文献

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{{ truncateString('Gail D'Onofrio', 18)}}的其他基金

Yale-METRO Metropolitan Emergency Trial netwoRK to advance patient Outcomes
耶鲁大学-METRO 大都会紧急试验网络可改善患者的治疗效果
  • 批准号:
    10552382
  • 财政年份:
    2023
  • 资助金额:
    $ 128.6万
  • 项目类别:
Clinical Trials Network: Admin Supplement: Integrating MOUD with BUP in Non-medical Community Settings
临床试验网络:管理补充:在非医疗社区环境中将 MOUD 与 BUP 集成
  • 批准号:
    10801347
  • 财政年份:
    2023
  • 资助金额:
    $ 128.6万
  • 项目类别:
Clinical Trials Network New England Consortium Node: Admin Supplement CTN0131
临床试验网络新英格兰联盟节点:管理补充 CTN0131
  • 批准号:
    10655837
  • 财政年份:
    2022
  • 资助金额:
    $ 128.6万
  • 项目类别:
National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node
国家药物滥用研究所临床试验网络:新英格兰联盟节点
  • 批准号:
    10684501
  • 财政年份:
    2022
  • 资助金额:
    $ 128.6万
  • 项目类别:
Clinical Trials Network New England Consortium Node: Admin Supplement CTN0126
临床试验网络新英格兰联盟节点:管理补充 CTN0126
  • 批准号:
    10655828
  • 财政年份:
    2022
  • 资助金额:
    $ 128.6万
  • 项目类别:
The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
  • 批准号:
    10450554
  • 财政年份:
    2021
  • 资助金额:
    $ 128.6万
  • 项目类别:
The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
  • 批准号:
    10442107
  • 财政年份:
    2021
  • 资助金额:
    $ 128.6万
  • 项目类别:
The National Drug Abuse Clinical Trials Network: New England Consortium Node
国家药物滥用临床试验网络:新英格兰联盟节点
  • 批准号:
    10451986
  • 财政年份:
    2021
  • 资助金额:
    $ 128.6万
  • 项目类别:
EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder
EMBED:以用户为中心的临床决策支持的实用试验,以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍
  • 批准号:
    9928151
  • 财政年份:
    2018
  • 资助金额:
    $ 128.6万
  • 项目类别:
EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder
EMBED:以用户为中心的临床决策支持的实用试验,以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍
  • 批准号:
    10379284
  • 财政年份:
    2018
  • 资助金额:
    $ 128.6万
  • 项目类别:
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