EVON MEDICS LLC — Department of Health and Human Services SBIR Phase I: NIDA

Description

The Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Cortex TrainingCBOTis an alternative strategy for relapse prevention in patients with Opioid UseOUDand other substance use disordersSUDOpioid and other forms of drug addiction can be defined as a failure to control drug seeking behaviorand reflect an exaggerated drive to consume drugsand or an inability to engage in outcome guided behaviors involving non drug rewards such as foodhealthsocial status and moneyIn contrast to overlearned drug related associationsnon drug outcomes are often less well established and need to be inferred or mentally simulatedThe orbitofrontal cortexOFCplays important role in regulation of addiction through provision of an associative structurei ecognitive mapfor these mental simulationsAs a resultOFC inactivation or direct injury from cocaine use or other sourceslead to repetitive drug useOn the other handeven brief optogenetic activation of OFC activity produce sustained changes in OFC dependent behaviorsincluding reduced self administration of drugs in neurobiology studiesUnfortunatelyboth cocaine and opioid use negatively impair OFC structure functionthereby fueling recurrence use of this drug through impairment in OFC based outcome guided behaviors for non drug rewardsRelapses in these patients is further compounded by emotion dysregulation since the OFC is a key structure involved in prefrontaltopdownregulation of emotional appraisalThereforeneurostimulation of OFC to enhance OFC plasticity has solid scientific premise for treatment of opioid addictionthrough improvement of outcome guided behavior and affective regulationHoweverthe ventral location of the OFC at the base of the skull makes it less accessible for non invasive stimulation using direct transcutaneous current stimulation or transcranial magnetic stimulationAn alternative strategy to improve long term opioid abstinence would be to use high fidelity chemosensory and computerized olfactory training approach to stimulate the OFCrepeatedly and intensivelyto influence OFC plasticity and enable more consistent recruitment of this region over timefor outcome guided behaviors involving non drug outcomesand for voluntary suppression of negative emotionThe small businessEvon Medics LLC and Howard UniversityHUhave created a home based olfactory pulsing prototype called Computerized Chemosensory Based Orbitofrontal Cortex TrainingCBOTto enable homebased neuromodulation of the OFC for treatment of OUDResult of our pilot feasibility study in OUD samples suggest that CBOT can minimize withdrawal symptomsreduce drug cravingsenhance positive affect and reduce rate of positive urine drug testsWe propose a PhaseSBIR application toestablish CBOT stimulation parameters needed to maximally improve outcome inference and emotion regulation in OUDAimand conduct a pilot test of short term effectiveness of CBOT treatment in reduction of recurrent positive urine drug tests overweeks inOUD patients defined by recurrent monthly drug relapse in the past yearProject success will be enhanced through strong collaborations between Evon Medics and HU investigatorsThe investigative team has significant experience in product and business developmentOUD researcholfactory neuroscienceand development and evaluation of OUD interventionsCompletion of grant activities will lead to an optimized CBOT product that overcome the drawbacks of traditional olfactory therapy and other noninvasive OFC modulation approaches in prevention of substance relapse in OUD populations with high relapse rateNARRATIVE Opioid Use DisordersOUDcause significant burden to individualsfamilies and the societyWe developed a cost savinghome basedalternative strategythe repetitive computerized olfactory therapyCOTto alleviate affective and motivational disorders of the brain in NIH funded studiesWe propose to optimize the COT prototype for prevention of drug relapses in OUD through targeted modulation of orbitofrontal cortex function to enhance behavior that involves non drug outcomes in OUD patients