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, 在阿片类药物治疗计划(OTP)之外扩大美沙酮的使用。荟萃分析和CTN 0027证明美沙酮中的保留高于BUP。造成保留率低的因素 基于办公室BUP可能包括较低的激动剂活性、较差的BUP依从性、多种物质的使用 不充分的行为服务、患者偏好,以及共同发生的状况(即,慢性疼痛)。 临床医生目前有2种选择,用于无法从基于办公室的BUP中获益的患者。他们 可以尝试加强BUP服务或将患者转介到美沙酮OTP。我们建议 评估所需的新选择-基于办公室的美沙酮处方(根据研究豁免, 受管制物质法)与美沙酮配药在药房或药物配药单位。 同时,在美国,获得阿片类药物使用障碍的药物的特点是: 严重的种族和城市/农村差异也可以通过基于办公室的美沙酮来解决。 我们建议进行一项6个地点的混合有效性实施试验,以比较:1) 美沙酮,其中当前基于办公室的BUP处方者管理转换和继续 美沙酮与当地美沙酮配药机构(药房或其他OTP附属机构)合作 药物单位)与; 2)增强型BUP,其中办公室BUP提供者继续BUP 治疗,同时提供增强的行为治疗和/或实施策略,以解决 520例患者的依从性(如有指征)(直接观察治疗、每周三次BUP或缓释BUP) 未从基于诊室的BUP中获得最佳获益的患者。在目标1中,我们将培训6名大型办公室BUP 为美沙酮提供院外给药/配药。在目标2中,我们将评估 基于办公室的美沙酮与增强型BUP在治疗保留方面的比较有效性, 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 确定患者、提供者和卫生部门实施障碍和促进因素的框架- 系统层面的办公室美沙酮。我们的团队包括早期研究人员,利益相关者 有生活经验的人,受过初级保健培训的研究人员, 医学/精神病学,临床试验,差异,定性研究和实施科学 在CTN开展研究、评价基于办公室的丁丙诺啡、基于办公室的 美沙酮和基于药房的美沙酮分发。这将是第一项研究:1) 利用经验丰富的BUP处方者,他们将学习处方美沙酮; 2)评估 有效性办公室为基础的美沙酮在高风险的病人没有被保留在BUP;和3) 评估病人和系统的障碍和促进者,以办公室为基础的美沙酮。

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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