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
• 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
• 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

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 行为服务不足、患者偏好和共存疾病（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现科学 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。