MedicaSafe Inc — Department of Health and Human Services STTR Phase I: R41

Description

DESCRIPTION provided by applicant This STTR application proposes development of MedicaSafe Inc andapos s Multimodal Analgesic Protection System MAPSafe Built around MedicaSafeandapos s proprietary Medication Therapy Optimization MTO technology MAPSafe will be designed to mitigate the myriad risks associated with prescription opioid use post operatively and throughout recovery after surgery Although prescription opioids are a mainstay of acute and chronic pain management their use is associated with numerous risks The misuse and abuse of prescription opioids has become a widespread public health problem in the United States and iatrogenic exposure to opioids postoperatively may lead to persistent opioid use In collaboration with Stanford University MedicaSafeandapos s Multimodal Analgesic Protection System MAPSafe will be designed to mitigate opioid misuse and abuse delayed opioid cessation and the subsequent development of chronic opioid use The Analgesic Regimen Control ARC device represents the foundational technology for the complete MAPSafe program An information motivation behavioral skills IMB model will serve as the theoretical foundation for development of all MAPSafe clinical content components which will include a Phase I Smart Tapering Module Opioid Induced Constipation Module and Safe Disposal Module Phase I will involve empirical development and feasibility testing of the MAPSafe service Activities with patients and experts in pain management will include Joint Application Development JAD panels to determine feasible components of the final system including the ARC device and related clinical content a randomized comparative pilot study to to compare performance of the MAPSafe program to treatment as usual TAU in a real world clinical environment at Stanford University and Phase II development activities including development of a larger randomized controlled trial RCT protocol testing the MAPSafe program at Stanford University and overcoming regulatory hurdles including obtaining a special Drug Enforcement Administration DEA license to conduct the proposed Phase II trial PUBLIC HEALTH RELEVANCE Although prescription opioids are standard of care for patients with acute post operative pain their use is associated with numerous risks including misuse abuse adverse health effects and persistent opioid use This research will address the critical public health problem of opioid misuse and abuse by developing a technology guided system for patients with acute post operative pain that will mitigate the substantial risks associated wih the use of prescription opioids post operatively and throughout recovery after surgery