BoostPrime, A Novel Digital Therapeutic for Craving Mitigation 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。

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.