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) 每年影响 160 万美国人，并造成重大影响 阿片类药物过量流行导致发病率和死亡率。尽管 FDA 批准了 3 种有效药物 OUD 治疗（MOUD），在所有受 OUD 影响的人中，只有一小部分人进行了有效的 MOUD， 其中，只有更小部分坚持治疗足够长的时间以实现稳定缓解。虽然 COVID-19 大流行导致了 OUD 现有治疗格局的广泛破坏，它还 强调了技术在 OUD 治疗中的应用机会，包括广泛应用 远程医疗的利用，得到了多层次监管变革的进一步支持。传统的处方者 实体诊所和初创远程医疗企业在利用方面迅速适应了新环境 远程医疗作为提供 MOUD 的主要手段。 2020 年 3 月，美国远程医疗的使用情况 不到1个月时间增长了154%。 MOUD 远程医疗的拥护者认为改善了访问，增加了 可行性和便利性以及减少耻辱作为潜在的好处。尽管得到了大规模的拥抱 去年 MOUD 的远程医疗，有证据表明 COVID-19 产生了不同程度的负面影响 OUD 患者大流行，包括用药过量死亡率增加。远程医疗存在局限性 与亲自护理相比，包括转移或滥用处方药物的风险更大。最好的 实践，例如如何完成高保真药物筛选或哪些患者可能更适合 个人护理尚未建立，无法跟上提供者采用的步伐 远程医疗，特别是没有接受成瘾培训的从业者提供 MOUD。 随着 SARS-Co-V2 疫苗接种率的增加，以及提供安全、有效的疫苗接种的机会也随之增加。 个人护理，了解远程医疗 MOUD 与面对面护理的优点和局限性至关重要 重要的是，特别是因为它有可能影响远远超出大流行范围的监管变化。赶紧进去 公共卫生危机不允许采取基于证据的方法来实现比较有效性 使用远程医疗 MOUD 和面对面 MOUD 的研究试验。 我们建议进行早期 II 期临床试验，其中 50 名寻求 MOUD 的患者将被随机分组 分配给两个臂之一：第 1 臂将接受亲自诱导和舌下含服维持剂量 丁丙诺啡或 MOUD 照常进行，第 2 组将完成舌下含服诱导和维持给药 丁丙诺啡通过综合远程医疗会议、远程医疗 MOUD、利用标准化协议 对于我们的成瘾专家开发的每个医疗保健提供者课程。这种远程医疗 协议作为 MOUD 中基于证据的实践整合的模型，可供非 大规模的成瘾专家。我们的主要结果是保留治疗 12 周。迄今为止，这 这将是第一个将远程医疗 MOUD 与通常的 MOUD 进行比较的前瞻性、随机、对照试验。