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 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。