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）和扩大阿片类药物治疗计划（OTP）以外的元通酮的访问。荟萃分析和CTN 0027证明，在Metagadone中的保留率高于BUP。导致低保留率的因素在基于办公室的BUP中，可能包括较低的激动剂活动，bup依从性差，多核能使用，行为服务不足，患者偏好和同时发生的状况（即慢性疼痛）。目前，临床医生为无法从办公室BUP中最佳受益的患者提供2种选择。他们可以尝试增强BUP服务或将患者转介到OTP中以获取Metagadone。我们建议评估所需的新选项 - 基于办公室的MEDADADONE处方（在研究豁免下用方法载体分配在药房或药物分配单元中的受控物质法。同时，美国获得阿片类药物使用障碍的药物的特点是基于办公室的Meadadone也可以解决深刻的种族和城市/农村分布。我们建议进行6个站点混合有效性实施试验，以比较：1）基于办公室的当前基于办公室的BUP处方者管理转换和延续的方法adone 与当地MethodAdone分配设施（药房或其他OTP相关的方法）合作药物单位）与; 2）增强BUP，基于办公室的BUP提供商继续BUP 治疗同时提供了增强的行为治疗和/或实施策略以解决如果指示（直接观察到治疗，每周三次bup或延长释放bup），520 患者无法从基于办公室的BUP中受益最佳。在AIM 1中，我们将培训6个大型基于办公室的BUP 为Metagadone提供异地给药/分配的站点。在AIM 2中，我们将评估基于办公室的方法adone与增强BUP在治疗保留率的比较有效性随机化6个月。在AIM 3中，我们将使用混合方法和实施科学确定患者，提供者和健康的框架和促进者的框架 - 基于办公室的MEDADONE的系统级。我们的团队完成了早期调查员，利益相关者和具有现场经验的人，接受过初级保健，成瘾培训的知名研究人员医学/精神病学，临床试验，分布，定性研究和实施科学已有在CTN进行研究的经验，评估基于办公室的丁丙诺啡，基于办公室 Metagadone和基于药房的分配方法。这将是：1）的第一个研究利用经验丰富的BUP处方者，他们会学会准备MethodAdone； 2）评估有效性基于办公室的方法adone对未保留在BUP中的高风险患者； 3）评估患者和系统障碍以及基于办公室的Meadadone的促进剂。