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.
Public Health Relevance Statement: PROJECT NARRATIVE Opioid use disorder (OUD) and related substance use disorders are highly damaging to individuals and society. Cravings and self-control are key contributors to OUD relapse which remain underserved by current treatments/tools. We propose to develop and validate a customized digital therapeutic software intervention to address these issues ("BoostPrime") for FDA approval/clearance as medical device.
Project Terms: Adoption; Architecture; Engineering / Architecture; Calibration; Cessation of life; Death; Pharmacotherapy; Drug Therapy; drug treatment; Exercise; Exhibits; Feedback; Freezing; Government; Health; Recording of previous events; History; histories; Human; Modern Man; Insurance Carriers; Insurers; Maps; Medical Device; Persons; Outpatients; Out-patients; Patients; Psychometrics; Psychotherapy; Psychological reinforcement; Reinforcement; Relapse; Research; research and development; Development and Research; R & D; R&D; Risk; Risk Management; Societies; Computer software; Software; Substance Use Disorder; substance use and disorder; Testing; Measures; improved; Clinical; Specified; Specific qualifier value; Phase; Variation; Variant; Training; disability; insight; Individual; Groups at risk; People at risk; Persons at risk; Populations at Risk; tool; Impaired cognition; Cognitive Disturbance; Cognitive Impairment; Cognitive decline; Cognitive function abnormal; Disturbance in cognition; cognitive dysfunction; cognitive loss; programs; Event; Clinic; Pattern; System; drug craving; Services; experience; success; cohort; High Performance Computing; high-end computing; novel; peer; Self-control as a personality trait; self control; Modeling; craving; Intervention; Intervention Strategies; interventional strategy; Documentation; Cell Phone; Cellular Telephone; Mobile Phones; iPhone; smart phone; smartphone; Cellular Phone; Provider; Address; Symptoms; Data; Measurable; National Institute of Drug Abuse; NIDA; National Institute on Drug Abuse; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Process; Development; developmental; Pathway interactions; pathway; cognitive training; data grid; datagrid; distributed computing; cluster computing; designing; design; Outcome; Population; innovate; innovative; innovation; Impairment; high risk; high reward; arm; cognitive process; cognitive burden; cognitive load; opiate use disorder; opioid use disorder; preservation; adaptive intervention; data pipeline; digital therapeutics; digital therapy; digital treatment; substance using; substance use; medication for opioid use disorder
