Implicit Cognition Assessments for Risk of Prescription Opioid Abuse

Period of Performance: 04/01/2015 - 03/31/2016


Phase 1 SBIR

Recipient Firm

Medicasafe, Inc.
New York, NY 10013
Principal Investigator


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.