A Randomized, Controlled Trial of Sublingual Buprenorphine through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

通过远程医疗与常规亲自护理治疗阿片类药物使用障碍的舌下含服丁丙诺啡的随机对照试验

• 批准号: 10431319
• 负责人: Christina A Brezing
• 金额: $ 23.99万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10431319
• 关键词: 2019-nCoV; Adverse effects; Advocate; Affect; American; Authorization documentation; Buprenorphine; Businesses; COVID-19 pandemic; COVID-19 pandemic effects; Caring; Clinic; Clinical Trials; Comparative Effectiveness Research; Coronavirus; Cost Sharing; Death Rate; Disease remission; Dose; Dropout; Drug Prescriptions; Drug Screening; Ecological momentary assessment; Economics; Effectiveness; Environment; Epidemic; Evidence based practice; FDA approved; Federally Qualified Health Center; Future; Grant; Health Insurance Portability and Accountability Act; Health Personnel; Healthcare; Healthcare Systems; Home; Improve Access; Individual; Infection Control; Maintenance; Measures; Modeling; Morbidity - disease rate; Opioid; Outcome Measure; Outpatients; Patient Preferences; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Phase II Clinical Trials; Policies; Protocols documentation; Provider; Public Health; Randomized; Randomized Controlled Trials; Regulation; Risk; Rural Health Centers; Security; Self Administration; Serious Adverse Event; Services; Site; Social Distance; Specialist; Standardization; Symptoms; Technology; Telemedicine; Text; Time; Toxicology; Training; United States Centers for Medicare and Medicaid Services; United States Dept. of Health and Human Services; United States Substance Abuse and Mental Health Services Administration; Urine; Vaccination; Visit; Withdrawal; Withdrawal Symptom; addiction; arm; craving; demographics; evidence base; expectation; improved; medication compliance; mortality; opioid overdose; opioid treatment program; opioid use; opioid use disorder; overdose death; pandemic disease; payment; pill; pilot trial; primary outcome; prospective; provider adoption; response; satisfaction; social stigma; substance abuse treatment; telehealth; trial comparing; virtual visit; waiver

Opioid Use Disorder (OUD) effects 1.6 million Americans per year, and contributes to significant morbidity and mortality, driven by the opioid overdose epidemic. Despite 3 FDA approved, effective medication treatments for OUD (MOUD), among all people affected by OUD, only a fraction engage in effective MOUD, and of those, an even smaller fraction remain in treatment long enough to achieve stable remission. While the COVID-19 pandemic resulted in widespread disruption in the existing treatment landscape for OUD, it also highlighted opportunities for applications of technology in the treatment of OUD, including widespread utilization of telehealth, that were further supported by multi-level regulatory changes. Prescribers in traditional brick-and-mortar clinics and start-up telehealth businesses quickly adapted to the new environment in utilizing telemedicine as a primary means of providing MOUD. In March 2020, utilization of telehealth in the US increased 154% in less than 1 month. Advocates of telehealth for MOUD identify improved access, increased feasibility, and convenience with diminished stigma as potential benefits. Despite the largescale embrace of telehealth for MOUD during the last year, evidence points to a differentially negative impact of the COVID-19 pandemic on patients with OUD, including increased overdose death rates. There are limitations of telehealth as compared to in-person care, including greater risk of diversion or misuse of prescribed medications. Best practices, such as how to complete high fidelity drug screening or which patients may be better suited to in person care, have not been established and have not been able to keep up with the pace of provider adoption of telehealth, particularly as practitioners without addiction training provide MOUD. As vaccination rates against SARS-Co-V2 increase, along with the opportunity to provide safe, in- person care, understanding the benefits and limitations of telehealth MOUD vs in-person care is critically important, especially as it has the potential to impact regulatory changes far beyond the pandemic. Haste in the public health crisis did not permit an evidence-based approach to allow for comparative effectiveness research trials in the use of telehealth MOUD and in-person MOUD. We propose an early Phase II clinical trial, in which 50 patients seeking MOUD will be randomly assigned to one of two arms: Arm 1 will receive in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual, and Arm 2 will complete induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions, telehealth MOUD, utilizing a standardized protocol for each healthcare provider session that has been developed by our addiction specialists. This telehealth protocol serves as a model of the integration of evidence-based practices in MOUD and could be used by non- addiction specialists at scale. Our primary outcome will be retention in treatment for 12-weeks. To date, this would be the first prospective, randomized, controlled trial comparing telehealth MOUD to MOUD as usual.

阿片类药物使用障碍（OUD）每年160万美国人，并有助于重大 阿片类药物过量流行驱动的发病率和死亡率。尽管有3次FDA批准，有效的药物 Oud的治疗（MOUD），在所有受Oud影响的人中，只有一小部分从事有效的穆德， 在这些方面，较小的部分在治疗中的时间足够长，足以实现稳定的缓解。而 COVID-19大流行导致现有的OUD治疗景观的普遍破坏，也是如此 强调了技术在OUD治疗中应用的机会，包括广泛 多级法规变更进一步支持远程医疗的利用。传统的处方者 实体诊所和启动远程医疗业务迅速适应了新环境 远程医疗是提供穆德的主要手段。 2020年3月，美国远程医疗的利用 在不到1个月的时间内增加了154％。远程医疗的拥护者以识别改进的访问，增加 可行性和便利性，污名化降低是潜在的好处。尽管有大规模的拥抱 去年，莫德的远程医疗指出，证据表明，covid-19 OUD患者的大流行，包括过量死亡率升高。有远程医疗的局限性 与面对面护理相比，包括更大的转移风险或滥用处方药。最好的 做法，例如如何完成高保真药物筛查或更适合哪些患者 人关怀，尚未建立，也无法跟上提供者采用的速度 远程医疗，尤其是在没有成瘾培训的从业者提供穆德时。 随着针对SARS-CO-V2的疫苗接种率的增加，以及提供安全，内在的机会 人关怀，了解远程医疗莫德vs亲自护理的好处和局限性是至关重要的 重要的是，尤其是因为它有可能影响远远超出大流行的监管变化。急忙进来 公共卫生危机不允许基于证据的方法来提高比较效率 在使用远程医疗穆德和面对面穆德的研究试验。 我们提出了一项II期早期临床试验，其中50名寻求MOUD的患者将是随机的 分配给两个武器之一：ARM 1将获得面对面的诱导和维护剂量的舌下剂量 丁丙诺啡或像往常一样穆德，手臂2将完成舌下的诱导和维护剂量 丁丙诺啡通过全面的远程医疗会议，远程医疗穆德，利用标准化协议 对于我们成瘾专家开发的每个医疗保健提供者会议。这个远程医疗 协议是MOUD中基于证据实践的整合的模型，非 - 可以使用 成瘾专家大规模。我们的主要结果将是在12周的治疗中保留。迄今为止，这个 将是第一个前瞻性，随机，对照的试验，将远程医疗穆德与穆德进行比较。