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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：
Gail D'Onofrio
金额：
$ 23.31万
依托单位：
YALE UNIVERSITY
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

来源：
https://reporter.nih.gov/project-details/10451986
关键词：
Address Adherence Agonist Behavior Therapy Behavioral Buprenorphine Clinical Trials Clinical Trials Network Directly Observed Therapy Drug abuse Health Personnel Health system Learning Medicine Meta-Analysis Methadone Methods New England Opiate Addiction Opioid Patient Preferences Patients Pharmaceutical Preparations Pharmacy facility Primary Health Care Provider Psychiatry Qualitative Research Randomized Research Research Personnel Services Site System Testing Training United States addiction base buprenorphine treatment chronic pain comparative effectiveness effectiveness evaluation effectiveness implementation study effectiveness implementation trial experience high risk implementation barriers implementation facilitators implementation framework implementation science opioid treatment program opioid use disorder polysubstance use prescription opioid rural disparities

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。