Implicit Cognition Assessments for Risk of Prescription Opioid Abuse

描述(由申请人提供)：这项SBIR第一阶段申请建议开发MedicaSafe的隐含处方滥用认知工具包(Impact)，这是一套由技术支持的认知评估工具，可显著增强医生检测阿片类药物治疗患者滥用阿片类药物迹象的能力。MedicaSafe的影响将包括两种最有效的隐含措施--Implici关联测试(IAT)和药物Stroop任务--的处方阿片类药物特定版本。影响评估将是一种简短的计算机化措施，它将向医生通报影响物质使用行为的患者特定的、无意识的阿片类药物相关认知，大大改进目前提供者可用的措施，并改善阿片类药物治疗患者的整体临床护理。过去20年，处方阿片类药物用于治疗慢性非癌症疼痛的数量以惊人的速度增加。对处方阿片类药物滥用和滥用的担忧导致美国食品和药物管理局(FDA)采取新的行动来实施安全使用措施，如风险评估和缓解策略(REMS)。尽管人们对处方阿片类药物滥用流行的担忧继续增加，但每年仍有1亿多美国人遭受慢性疼痛，对身心健康造成重大损害。为了应对这一双重公共卫生挑战，该领域的主要决策者现在建议采取一种平衡的方法，强调明智的阿片类药物处方和持续的风险监测。需要在评估战略方面取得新的进展，以便能够采取一种平衡的方法，最好地解决患者的痛苦，同时减少处方阿片类药物的滥用和滥用。神经科学的最新发现使研究人员能够洞察物质使用者的无意识想法和动机。本阶段第一阶段建议将这些进展扩展到处方阿片类药物使用的研究，以应对处方阿片类药物滥用和滥用带来的公共卫生挑战。第一阶段将涉及对拟议的处方阿片滥用隐含措施的经验开发和验证。一个由内隐测量方法、内隐认知和成瘾方面的关键意见领袖组成的专家小组将帮助MedicaSafe工作人员实现这一目标。在开发出隐含评估后，将在疼痛管理诊所进行一项验证研究，评估MedicaSafe的隐含评估添加到当前最有效的显式筛查和持续监测阿片类药物滥用的能力。这一阶段第一阶段的重点将是确定隐含评估的有效性以及它们在检测阿片类药物滥用方面的临床效用，这超出了医生目前可用的评估策略。

DESCRIPTION (provided by applicant): This SBIR Phase I application proposes development of MedicaSafe's Implicit Prescription Abuse Cognitive Toolkit (IMPACT), a technology-enabled suite of cognitive assessment tools to significantly add to physicians' ability to detect signs of opioid misuse and abuse in patients on opioid therapies. MedicaSafe's IMPACT will comprise prescription opioid-specific versions of two of the most validated implicit measures -- the Implici Association Test (IAT) and Drug Stroop Task. IMPACT assessments will be brief, computerized measures that will inform physicians of the specific, unconscious opioid-related cognitions of their patients that affect substance use behaviors, significantly improving upon the measures currently available to providers and improving clinical care overall for patients on opioid therapy The use of prescription opioids to treat chronic non-cancer pain has increased at a staggering pace over the last two decades. Concern over the misuse and abuse of prescription opioids has led to new actions by the U.S. Food and Drug Administration (FDA) to implement safe-use measures, such as Risk Evaluation and Mitigation Strategies (REMS). Although concern over the epidemic of prescription opioid abuse continues to increase, more than 100 million Americans suffer from chronic pain each year, causing significant impairment in physical and emotional health. To address this dual public health challenge, key decision makers in the field now recommend a balanced approach that stresses judicious opioid prescribing and ongoing risk monitoring. New advancements in assessment strategies are needed to enable a balanced approach that will best address patient suffering while mitigating the misuse and abuse of prescription opioids. Recent findings in neuroscience have allowed researchers to gain insight into the unconscious thoughts and motivations of substance users. This Phase I proposes to extend these advancements to the study of prescription opioid use in order to address the public health challenge of prescription opioid misuse and abuse. Phase I will involve the empirical development and validation of the proposed implicit measures of prescription opioid misuse. An expert panel of key opinion leaders in implicit measure methodology, implicit cognition, and addiction will assist MedicaSafe staff in this goal. Upon development of the implicit assessments, a validation study evaluating the ability of MedicaSafe's implicit assessments to add to the current most validated explicit screeners and ongoing monitors of opioid misuse will be conducted at a pain management clinic. The focus of this Phase I will be to establish the implicit assessments' validity as well as their clinical utility in detecting opioid misuse above ad beyond the current assessment strategies available to physicians.