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

基本信息

  • 批准号:
    10451986
  • 负责人:
  • 金额:
    $ 23.31万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2021
  • 资助国家:
    美国
  • 起止时间:
    2021-09-01 至 2022-02-28
  • 项目状态:
    已结题

项目摘要

There is an urgent need to address sub-optimal retention in office-based buprenorphine (BUP) and expand access to methadone outside of opioid treatment programs (OTP). Meta-analyses and CTN 0027 demonstrate that retention in methadone is higher than BUP. Factors contributing to low retention in office-based BUP may include lower agonist activity, poor BUP adherence, polysubstance use, insufficient behavioral services, patient preference, and co-occurring conditions (i.e., chronic pain). Clinicians currently have 2 options for patients not optimally benefitting from office-based BUP. They can attempt to enhance BUP services or refer the patient to an OTP for methadone. We propose to evaluate a needed new option – office-based methadone prescribing (under a research exemption to the Controlled Substance Act) with methadone dispensing at a pharmacy or medication dispensing unit. Simultaneously, access to medications for opioid use disorder in the United States is characterized by profound racial and urban/rural disparities which could also be addressed by office-based methadone. We propose to conduct a 6 site hybrid effectiveness implementation trial to compare: 1) Office-based methadone where the current office-based BUP prescriber manages a switch to and continuation of methadone in partnership with a local methadone dispensing facility (pharmacy or other OTP-affiliated medication unit) versus; 2) Enhanced BUP where the office-based BUP provider continues BUP treatment while providing enhanced behavioral treatment and/or implementing strategies to address adherence if indicated (directly observed therapy, thrice-weekly BUP, or extended-release BUP), in 520 patients not optimally benefiting from office-based BUP. In Aim 1 we will train 6 large office-based BUP sites to provide methadone with offsite administration/dispensing. In Aim 2 we will evaluate the comparative effectiveness of office-based methadone versus Enhanced BUP on treatment retention at 6 months after randomization. In Aim 3 we will use mixed methods and an implementation science framework to identify implementation barriers and facilitators at the patient, provider and health- systems level for office-based methadone. Our team comprising early stage investigators, stakeholders and people with lived experience, established researchers trained in primary care, addiction medicine/psychiatry, clinical trials, disparities, qualitative research and implementation science has experience conducting research in the CTN, evaluating office-based buprenorphine, office-based methadone and pharmacy-based dispensing of methadone. This would be the first study to: 1) capitalize on experienced BUP prescribers who would learn to prescribe methadone; 2) evaluate the effectiveness office-based methadone in patients at high risk for not being retained in BUP; and 3) assess patient and system barriers and facilitators to office-based methadone.
迫切需要解决基于办公室的丁丙诺啡(BUP)的次优保留问题 扩大在阿片类药物治疗计划(OTP)之外获得美沙酮的机会。Meta分析与CTN 0027表明美沙酮在美沙酮中的保留率高于BUP。导致保留率低的因素 办公室基础BUP可能包括激动剂活性较低、BUP依从性差、多物质使用 行为服务不足、患者偏好和共生情况(如慢性疼痛)。 对于没有从办公室BUP中获得最佳益处的患者,临床医生目前有两种选择。他们 可尝试加强BUP服务或转介患者到OTP接受美沙酮治疗。我们建议 评估所需的新选项-基于办公室的美沙酮处方(根据研究豁免 受控物质法),在药房或药物配药单位配发美沙酮。 同时,在美国获得治疗阿片类药物使用障碍的药物的特点是 严重的种族和城乡差距,也可以通过办公室使用的美沙酮来解决。 我们建议进行6个站点的混合有效性实施试验,以比较:1)基于办公室的 美沙酮,目前办公室的BUP处方员管理切换到并继续 美沙酮与当地美沙酮配药设施(药房或其他与OTP有关的机构)合作 药物单位)与;2)增强的BUP,其中基于办公室的BUP提供者继续BUP 治疗,同时提供增强的行为治疗和/或实施战略来解决 依从性(直接观察治疗、每周三次BUP或缓释BUP),在520 患者没有从基于办公室的BUP中获得最佳好处。在目标1中,我们将培训6个大型办公室BUP 为美沙酮提供异地给药/配药的地点。在目标2中,我们将评估 办公室美沙酮与增强型BUP治疗滞留的疗效比较 随机化后6个月。在目标3中,我们将使用混合方法和实施科学 框架,以确定患者、提供者和医疗保健方面的实施障碍和促进者- 办公用美沙酮的系统级别。我们的团队由早期调查人员、利益相关者组成 有生活经验的人,受过初级保健、成瘾培训的知名研究人员 医学/精神病学、临床试验、差异、定性研究和实施科学 在CTN进行研究、评估办公室用丁丙诺啡、办公室用丁丙诺啡的经验 美沙酮及药房美沙酮配药。这将是第一次对以下内容进行研究:1) 利用经验丰富的BAP处方师,他们将学习开美沙酮;2)评估 未保留在BUP中的高危患者的有效性办公室美沙酮;以及3) 评估患者和系统障碍以及办公室用美沙酮的促进者。

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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 项目类别:
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
  • 批准号:
    10801950
  • 财政年份:
    2023
  • 资助金额:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 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:
    $ 23.31万
  • 项目类别:

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