Project Grant R44DA053876

DELIVERING TRANSCUTANEOUS AURICULAR NEUROSTIMULATION TO IMPROVE TREATMENT RETENTION IN OPIOID USE DISORDER - CURRENTLY, THE UNITED STATES IS EXPERIENCING AN OPIOID EPIDEMIC IN THE USE OF PRESCRIPTION AND NON-PRESCRIPTION DRUGS THAT HAS CONTINUED TO RISE SINCE THE 1990'S. IN 2005, THERE WERE AN ESTIMATED 10 MILLION CHRONIC PAIN PARTICIPANTS RECEIVING DAILY, LONG-TERM TREATMENT WITH OPIOIDS. THE CONTINUING INCREASE IN OPIOID CONSUMPTION FROM 2005 TO 2017 SUGGESTS THAT THE NUMBER MAY NOW EXCEED 11 MILLION. UNFORTUNATELY, THE NEED FOR SAFE AND EFFECTIVE OPIOID WITHDRAWAL TREATMENT IS DEMANDING AND LARGELY UNMET. A PRIMARY CONSTRAINT ON THE OVERALL PERCENTAGE OF PHARMACOTHERAPY TREATMENT RECIPIENTS IS THE LIMITED AVAILABILITY OF LICENSED PHYSICIANS THAT CAN PRESCRIBE OPIOID-BASED PHARMACOTHERAPIES. PRESCRIPTION OPIOIDS POSE A VARIABLE LEVEL OF RISK ON RESPIRATORY DEPRESSION AND ABNORMAL CARDIAC ACTIVITY AND CAN ONLY BE OBTAINED FROM LICENSED OPIOID TREATMENT PROGRAMS. IN CONTRAST, NON-OPIOID PHARMACOTHERAPIES (LOFEXIDINE AND NALTREXONE) DO NOT REQUIRE A LICENSE, AND HAVE THE POTENTIAL TO BE MORE WIDELY ADMINISTERED. HOWEVER, THE TREATMENT EFFICACY AND RETENTION OF THESE MEDICATIONS ARE LIMITED, THUS SIGNIFICANTLY FEWER PATIENTS UTILIZE NON-OPIOID VS OPIOID PHARMACOTHERAPIES. DUE TO INADEQUATE AND SCARCE TREATMENT OPTIONS FINDING AN EFFECTIVE, NON-PHARMACOLOGICAL APPROACH THAT WOULD: 1) REQUIRE MINIMAL TRAINING, 2) BE READILY AVAILABLE TO PHYSICIANS AND ADVANCED CARE PROVIDERS, 3) HAVE A MINIMAL SIDE EFFECTS PROFILE, 4) PREVENT OR ELIMINATE THE USE OF OPIOIDS, AND 5) REMOVE THE FEAR OF EXPERIENCING ACUTE/PRECIPITATED WITHDRAWAL WOULD BE CRITICAL IN IMPROVING AND EXPANDING TREATMENT FOR OPIOID ADDICTION. ABUNDANT CLINICAL EVIDENCE EXISTS FOR THE RAPID AND EFFECTIVE REDUCTION OF SIGNS AND SYMPTOMS ASSOCIATED WITH OPIOID WITHDRAWAL THROUGH VARIOUS APPROACHES OF NON-INVASIVE NEUROSTIMULATION. WE PROPOSE USING TRANSCUTANEOUS AURICULAR NEUROSTIMULATION (TANTM) AS AN ADJUVANT TO NON-OPIOID PHARMACOTHERAPIES TO IMPROVE TREATMENT RETENTION BY FURTHER REDUCING OPIOID WITHDRAWAL SYMPTOMS AND CRAVINGS. SPARK BIOMEDICAL INC., HAS DEVELOPED A TAN SYSTEM, THAT REMOVES THE LIMITATIONS OF PERCUTANEOUS NEUROSTIMULATION SYSTEMS. SPARK'S SPARROWTM THERAPY SYSTEM UTILIZES A FLEXIBLE EARPIECE WITH EMBEDDED HYDROGEL ELECTRODES THAT ADHERE TO THE SKIN, THE EARPIECE IS DISPOSABLE AFTER USE, AND DELIVERS A MORE COMFORTABLE AND PRACTICAL THERAPY. ADDITIONALLY, THIS SYSTEM IS CAPABLE OF FULLY CUSTOMIZING STIMULATION PARAMETERS TO MATCH EACH PARTICIPANTS' THERAPEUTIC REQUIREMENTS. IT WAS HYPOTHESIZED THAT ACTIVATING AURICULAR CRANIAL NERVE BRANCHES VIA TAN WOULD CONFER A SIMILAR REDUCTION IN OPIOID WITHDRAWAL SYMPTOMS, MINUS THE DRAWBACKS OF PERCUTANEOUS NEUROSTIMULATION. THE SPARROW SYSTEM IS A WEARABLE, BATTERY-OPERATED, NEUROSTIMULATION DEVICE INTENDED TO TRANSCUTANEOUSLY STIMULATE NERVES IN AND/OR AROUND THE EAR. THE SPARROW IS CURRENTLY INDICATED AS A TRANSCUTANEOUS NERVE STIMULATOR THAT AIDS IN THE REDUCTION OF OPIOID WITHDRAWAL SYMPTOMS. THE GOAL OF THIS PROPOSED EFFORT IS TO EXPAND THE USE OF OUR SPARROW SYSTEM FOR THE REDUCTION IN OPIOID CRAVINGS AND LESSEN THE CHANCE OF RELAPSE.