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: 10630224
• 负责人: Christina A Brezing
• 金额: $ 19.99万
• 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 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10630224
• 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; Health Services; 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; Security; Self Administration; Serious Adverse Event; 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; authority; craving; demographics; evidence base; expectation; improved; medication compliance; mortality; opioid overdose; opioid treatment program; opioid use; opioid use disorder; overdose death; pandemic disease; patient retention; payment; pill; pilot trial; primary outcome; prospective; provider adoption; response; rural health clinic; satisfaction; social stigma; substance abuse treatment; telehealth; treatment as usual; 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