BoostPrime, A Novel Digital Therapeutic for Craving Mitigation in OUD

项目摘要 国家药物滥用研究所指出，“有更多的死亡，疾病和残疾， 物质使用比任何其他可预防的健康状况。在SUD中，特别是阿片类药物使用障碍 (OUD)，个人经常经历不受控制的渴望症状，即使接受治疗， OUD计划（MOUD，也称为MAT）的监督药物，包括支持性心理治疗， 对等恢复服务。此外，SUD患者在自我控制方面也有缺陷 认知过程我们建议解决食欲负担，并加强瞬时（秒/分钟） 范围）自我控制处理通过提供一个连续的解决方案，“BoostPrime”，作为一个基于智能手机 渴望支持的软件干预，结合新颖的认知训练练习。包含多行 初步研究建立Boost平台认知训练效果和症状效益高 利用者，并表明商业临床部署的可行性，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率提高战略;并使 FDA将告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 测试平台变体以告知最佳利用增强策略（即，自适应模型） 将在门诊接受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改善。活动将在重新提交以下文件时达到高潮： BoostPrime数字治疗包给FDA，作为对OUD渴望的预防性治疗。

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.