Transaction Description:
BOOSTPRIME, A NOVEL DIGITAL THERAPEUTIC FOR CRAVING MITIGATION IN OUD - PROJECT SUMMARY THE NATIONAL INSTITUTE ON DRUG ABUSE INDICATES THAT “THERE ARE MORE DEATHS, ILLNESS, AND DISABILITIES FROM SUBSTANCE USE THAN FROM ANY OTHER PREVENTABLE HEALTH CONDITION.” IN SUDS, AND PARTICULARLY OPIOID USE DISORDER (OUD), INDIVIDUALS FREQUENTLY EXPERIENCE UNCONTROLLED CRAVING SYMPTOMS, EVEN RECEIVING TREATMENT UNDER A SUPERVISED MEDICATION FOR OUD PROGRAM (MOUD, ALSO KNOWN AS MAT) INCLUDING SUPPORTIVE PSYCHOTHERAPY AND PEER RECOVER SERVICES. IN ADDITION, INDIVIDUALS WITH SUDS ARE NOTED TO HAVE IMPAIRMENTS IN SELF-CONTROL COGNITIVE PROCESSES. WE PROPOSE TO ADDRESS CRAVINGS BURDEN AND TO STRENGTHEN MOMENTARY (SECONDS/MINUTES RANGE) SELF-CONTROL PROCESSING BY DELIVERING AN ADJUNCTIVE SOLUTION, “BOOSTPRIME”, AS A SMARTPHONE-BASED SOFTWARE INTERVENTION FOR CRAVING SUPPORT, INCORPORATING NOVEL COGNITIVE TRAINING EXERCISES. WITH MULTIPLE LINES OF PRELIMINARY RESEARCH ESTABLISHING BOOST PLATFORM COGNITIVE TRAINING EFFECTS AND SYMPTOMATIC BENEFIT FOR HIGH UTILIZERS, AND INDICATING VIABILITY FOR CLINICAL DEPLOYMENT COMMERCIALLY, WE WILL NOW: REFINE THE OPERATOR INTERFACE AND SYSTEM DESIGN TO ACCOMMODATE UTILIZATION-ENHANCING STRATEGIES FOR PATIENTS AND PROVIDERS; AND ENGAGE THE FDA TO INFORM REGULATED DEVELOPMENT AND VALIDATION PLANS. IN PHASE II WE WILL CONDUCT LARGE-SCALE HUMAN TESTING OF PLATFORM VARIANTS TO INFORM AN OPTIMAL UTILIZATION-ENHANCEMENT STRATEGY (I.E., AN ADAPTIVE MODEL) WHICH WILL BE TESTED IN A PIVOTAL STUDY OF PATIENTS RECEIVING MOUD TREATMENT SUPPORT IN AN OUTPATIENT SETTING; FOR CRAVING BENEFITS AND MOMENTARY SELF-CONTROL IMPROVEMENTS. ACTIVITIES WILL CULMINATE IN DE NOVO SUBMISSION OF THE BOOSTPRIME DIGITAL THERAPEUTIC PACKAGE TO THE FDA, AS AN ADJUNCTIVE TREATMENT FOR CRAVINGS IN OUD.
