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BoostPrime, A Novel Digital Therapeutic for Craving Mitigation in OUD

BoostPrime，一种缓解 OUD 渴望的新型数字疗法

基本信息

批准号：
10689000
负责人：
Salil Patel
金额：
$ 31.99万
依托单位：
NXTECH INC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-15 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10689000
关键词：
Address Adoption Architecture Calibration Cellular Phone Cessation of life Clinic Clinical Computer software Data Development Documentation Event Exercise Exhibits Feedback Freezing Government Health High Performance Computing Human Impaired cognition Impairment Individual Insurance Carriers Intervention Maps Measurable Measures Medical Device Modeling National Institute of Drug Abuse Outcome Outpatients Pathway interactions Patients Pattern Persons Pharmacotherapy Phase Population Populations at Risk Process Provider Psychological reinforcement Psychometrics Psychotherapy Recording of previous events Relapse Research Risk Risk Management Self-control as a personality trait Services Small Business Innovation Research Grant Societies Specific qualifier value Substance Use Disorder Symptoms System Testing Training Validation Variant adaptive intervention arm cluster computing cognitive load cognitive process cognitive training cohort craving data pipeline design digital treatment disability drug craving experience high reward high risk improved innovation insight medication for opioid use disorder novel opioid use disorder peer preservation programs research and development substance use success tool

项目摘要

PROJECT SUMMARY The National Institute on Drug Abuse indicates that “there are more deaths, illness, and disabilities from substance use than from any other preventable health condition.” In SUDs, and particularly opioid use disorder (OUD), individuals frequently experience uncontrolled craving symptoms, even receiving treatment under a supervised medication for OUD program (MOUD, also known as MAT) including supportive psychotherapy and peer recover services. In addition, individuals with SUDs are noted to have impairments in self-control cognitive processes. We propose to address cravings burden and to strengthen momentary (seconds/minutes range) self-control processing by delivering an adjunctive solution, “BoostPrime”, as a smartphone-based software intervention for craving support, incorporating novel cognitive training exercises. With multiple lines of preliminary research establishing Boost platform cognitive training effects and symptomatic benefit for high utilizers, and indicating viability for clinical deployment commercially, we will now: refine the operator interface and system design to accommodate utilization-enhancing strategies for patients and providers; and engage the FDA to inform regulated development and validation plans. In Phase II we will conduct large-scale human testing of platform variants to inform an optimal utilization-enhancement strategy (i.e., an adaptive model) which will be tested in a pivotal study of patients receiving MOUD treatment support in an outpatient setting; for craving benefits and momentary self-control improvements. Activities will culminate in De Novo submission of the BoostPrime digital therapeutic package to the FDA, as an adjunctive treatment for cravings in OUD.

项目总结美国国家药物滥用研究所指出，“有更多的死亡、疾病和残疾来自物质的使用比任何其他可预防的健康状况都要好。肥皂泡，特别是阿片类药物使用障碍 (OUD)，个人经常出现失控的渴望症状，甚至在 OUD计划(Moud，也称为MAT)的监督药物治疗，包括支持性心理治疗和对等恢复服务。此外，人们注意到患有肥皂泡的人在自我控制方面存在障碍。认知过程。我们建议解决渴望负担，并加强瞬间(秒/分钟 Range)通过提供基于智能手机的辅助解决方案“BoostPrime”进行自我控制处理渴望支持的软件干预，结合新的认知训练练习。具有多行高中生Boost平台认知训练效果及对症效益的初步研究工具，并表明临床部署的商业可行性，我们现在将：完善操作员界面和系统设计，以适应患者和提供者的利用增强策略；并参与 FDA通知受监管的开发和验证计划。在第二阶段，我们将进行大规模的人类测试平台变体以提供最佳利用-增强策略(即，自适应模型) 这将在一项针对在门诊环境中接受Moud治疗支持的患者的关键研究中进行测试；渴望利益和短暂的自我控制能力的提高。活动的最终结果是De Novo提交将BoostPrime数字治疗包提交给FDA，作为对OUD的渴望的辅助治疗。