SBIR-STTR Award

Opioid abuse has become an epidemic with devastating health, social, and economic consequences for the United States. Drug overdose deaths have nearly tripled from 1999-2014. During 2015, drug overdoses accounted for 52,404 U.S. deaths, including 33,091 (63.1%) that involved an opioid (opioid pain relievers and heroin). Opioid analgesic overdose is now the leading cause of injury death in the U.S; in 2014, there were approximately one and a half times more drug overdose deaths than deaths from motor vehicle accidents. Treatment for an opioid use disorder (OUD) is a complex multifactorial process often involving medication assisted treatment (MAT) and requiring changes in deeply imbedded behaviors. Patients are treated in the clinic, but fight addiction in their daily lives. Rates of relapse are high, and access to supportive care is limited and costly. Treatment approaches must be tailored to address each patient's drug use patterns and drugrelated medical, psychiatric, and social problems. While a few online tools exist to assist patients in their recovery, current products offer only generalized information that may or may not be relevant and timely, or act solely as supportive social networking services. In previous work, we developed KIOS, an innovative software platform derived from nonlinear control theory. KIOS tracks multiple interacting symptoms to map patient trajectories and deliver evidence-based intervention strategies responsive to the specific needs of individuals. Accessible via computer or mobile devices, KIOS provides patients real time advice and reinforcement of lifestyle interventions to improve selfmanagement. KIOS also can provide between-visit reporting to clinicians via downloadable reports or direct online monitoring. Therefore, the goal of this project is to adapt KIOS to patients with an opioid use disorder. The development of this innovative tool to help patients manage OUD has the potential to have a profound impact on public health and achieve significant commercial success. This Phase I SBIR study has two Specific Aims: Specific Aim 1: Identify Patient Trajectories of OUD and Link Expert Advice to Changing Patient States Specific Aim 2: Build User Interfaces and Test Feasibility in Patients with OUD

Public Health Relevance Statement:
The U.S. is in the midst of an unprecedented opioid epidemic, with devastating social, economic and health consequences. The societal cost of opioid abuse is estimated to be $53.4 billion annually, which includes lost productivity, criminal justice costs, and medical costs. Real time delivery of intervention strategies responsive to patients' specific needs would improve outcomes, reduce healthcare costs, and have a significant impact on public health.

Project Terms:
Opioid Analgesics; opioid painkiller; opioid pain reliever; opioid pain medication; opioid anesthetic; opioid analgesia; opiate pain reliever; opiate pain medication; opiate analgesic; opiate analgesia; Behavior; Bipolar Disorder; manic depressive illness; manic depressive disorder; bipolar disease; bipolar affective disorder; Manic-Depressive Psychosis; Bipolar Affective Psychosis; Clinical Trials; Cognitive Therapy; cognitive behavioral treatment; cognitive behavioral therapy; cognitive behavioral modification; cognitive behavioral intervention; cognitive behavior therapy; cognitive behavior modification; cognitive behavior intervention; Cognitive Psychotherapy; Cognition Therapy; Computers; Cessation of life; Death; Heroin; Diamorphine; Diacetylmorphine; Pharmaceutical Preparations; drug/agent; Pharmaceutic Preparations; Medication; Drugs; Economics; Epidemic; Feedback; Focus Groups; Foundations; Goals; Health; Health Status; Level of Health; Maps; Methods; Motivation; opioid abuse; opioid drug abuse; opiate drug abuse; opiate abuse; Overdose; Patient Monitoring; Client satisfaction; Patient Satisfaction; Patients; Productivity; Public Health; Psychological reinforcement; Reinforcement; Relapse; Risk; Social Problems; social disturbance; Computer software; Software; Systems Theory; Technology; Testing; Time; United States; Work; Caregivers; Care Givers; Health Care Costs; Healthcare Costs; Health Costs; Criminal Justice; Medical Care Costs; medical costs; Self Management; Social Network; Injury; base; improved; Chronic; Clinical; Phase; Medical; Death Rate; Randomized Controlled Clinical Trials; Link; Ensure; Evaluation; Individual; Recovery; Opiates; Opioid; Summary Reports; self knowledge; self awareness; Self view; Self image; Personal awareness; Self Perception; drug use; Drug usage; world wide web; web; WWW; Internet; tool; Supportive care; Supportive Therapy; Consensus; Knowledge; fighting; Complex; Clinic; Pattern; System; Opiate Addiction; opioid dependent; opioid dependence; opioid addiction; Opiate Dependence; Visit; Services; success; novel; treatment program; vehicular accident; motor vehicle accident; Motor carrier accident; Reporting; social; Modeling; software development; developing computer software; develop software; Intervention; interventional strategy; Intervention Strategies; prevent; preventing; Address; Symptoms; Data; Small Business Innovation Research; SBIR; Small Business Innovation Research Grant; Monitor; Characteristics; Process; developmental; Development; cost; designing; design; life style intervention; lifestyle intervention; innovative; innovate; innovation; resistant; Resistance; analytical tool; Affective; Evidence based intervention; multidisciplinary; mobile device; handheld mobile device; usability; addictive disorder; addiction; prototype; commercialization; overdose death; prescription opiate; prescribed opioid; prescribed opiate; opioid medication; opiate medication; licit opioid; prescription opioid; mobile health; m-Health; mHealth; control theory; mobile technology; mobile platform; mobile computing; opiate use disorder; opioid use disorder; improved outcome; medication-assisted treatment; dashboard; opioid crisis; opiate crisis; opioid epidemic; societal costs; prescription opioid dependence; prescription opiate addiction; dependence on prescription opioids; addiction to prescription opioids; prescription opioid addiction

The opioid crisis is an epidemic with devastating health, social, and economic consequences for the United States. From 1999-2018, almost 450,000 people died from an overdose involving any opioid, including prescription and illicit opioids. Three million US citizens and 16 million individuals worldwide have had or currently suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US is estimated to be more than $200 billion annually. Treatment for OUD involves medication assisted treatment (MAT) combined with counseling or behavioral therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent drug use are high, and access to counseling is limited and costly. While MAT is standard of care and highly effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to address an individual patient's drug use patterns and drug-related medical, psychiatric, and social problems. While mobile tools exist to support OUD treatment, these products offer only generalized information and not personalized feedback that is responsive to each person's current status to support their individual recovery. In Phase I, we developed KIOS, an innovative software platform using nonlinear control theory. KIOS tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management during MAT. Phase I beta testing demonstrated significant reductions in key symptoms of OUD and high levels of engagement, usability and patient satisfaction. This project completes development of KIOS as a prescription digital health therapeutic suitable for FDA approval concomitant to MAT to treat OUD. This innovative tool to help patients manage OUD has the potential to have a profound impact on public health and achieve significant commercial success. This Phase II STTR study has three Specific Aims which are designed to attain FDA medical device approval: Specific Aim 1: Enhance Software Design and Features Specific Aim 2: Comply with Regulatory Requirements Specific Aim 3: Evaluate KIOS in a 12-week Randomized Controlled Trial

Public Health Relevance Statement:
PROJECT NARRATIVE Behavioral therapy is an important adjunct to medication assisted treatment for opioid use disorder. Currently available mobile tools to deliver behavioral interventions are limited in their ability to respond to changing conditions of individuals in recovery. This project seeks to develop on demand delivery of mobile intervention strategies responsive to patients' specific needs that if successful, would improve outcomes, reduce healthcare costs, and have a significant impact on public health.

Project Terms:
Absenteeism; Anxiety; Behavior; Behavior Therapy; Behavior Conditioning Therapy; Behavior Modification; Behavior Treatment; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Conditioning Therapy; behavior intervention; behavioral intervention; Clinical Trials; Combined Modality Therapy; Multimodal Therapy; Multimodal Treatment; combination therapy; combined modality treatment; combined treatment; multi-modal therapy; multi-modal treatment; Conflict (Psychology); Conflict; Counseling; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Economics; Epidemic; Feedback; Focus Groups; Goals; Health; Health Services Accessibility; Access to Care; access to health services; access to services; access to treatment; accessibility to health services; availability of services; care access; health service access; health services availability; service availability; treatment access; Maps; Medical Device; Moods; Morbidity - disease rate; Morbidity; mortality; Persons; opioid abuse; opiate abuse; opiate drug abuse; opioid drug abuse; Overdose; Pain; Painful; Client satisfaction; Patient Satisfaction; Patients; Public Health; Quality Control; Quality of life; QOL; Recurrence; Recurrent; Psychological reinforcement; Reinforcement; Research Personnel; Investigators; Researchers; Safety; Social Problems; social disturbance; Computer software; Software; Software Design; Designing computer software; Software Engineering; Computer Software Development; Computer Software Engineering; Systems Theory; Technology; Testing; Time; United States; Measures; Health Care Costs; Health Costs; Healthcare Costs; depressive symptoms; Emotional Depression; depression symptom; depressive; Self Management; base; improved; Acute; Clinical; Phase; Medical; Ensure; Individual; Recovery; Opioid; Opiates; satisfaction; Drug usage; drug use; Food and Drug Administration Device Approval; FDA Device Approval; Device Approval; Device Approval Process; Randomized Controlled Trials; Therapeutic; tool; Supportive Therapy; Supportive care; Complex; Clinic; Pattern; System; Opiate Dependence; opioid addiction; opioid dependence; opioid dependent; Opiate Addiction; experience; success; novel; Participant; Self-Report; Patient Self-Report; Reporting; social; Regulation; craving; response; Intervention Strategies; interventional strategy; Intervention; Effectiveness; Address; Symptoms; Data; M.D.; Doctor of Medicine; Ph.D.; PhD; Doctor of Philosophy; Economic Burden; NIDA; National Institute on Drug Abuse; National Institute of Drug Abuse; randomisation; randomization; randomly assigned; Randomized; Security; Small Business Technology Transfer Research; STTR; Principal Investigator; Process; Modification; Development; developmental; Behavioral; cost; software systems; design; designing; lifestyle intervention; life style intervention; innovation; innovate; innovative; Evidence based intervention; patient oriented; patient centered; handheld mobile device; mobile device; usability; addiction; addictive disorder; commercialization; FDA approved; standard of care; public health emergency; phase 1 study; Phase I Study; prescription opioid; licit opioid; opiate medication; opioid medication; prescribed opiate; prescribed opioid; prescription opiate; Good Clinical Practice; GCP standard; mHealth; m-Health; mobile health; mobile application; mobile app; mobile device application; trial design; control theory; personalized approach; Personalized medical approach; individualized approach; precision approach; tailored approach; opioid use disorder; opiate use disorder; individual patient; improved outcome; medication-assisted treatment; opioid epidemic; opiate crisis; opioid crisis; illicit opioid; illicit opiate; digital health; effectiveness study