This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $591,032 to Square2 Systems Inc. to develop a turnkey digital therapeutics platform called COGITO. COGITO aims to accelerate the development, evaluation, deployment, and scaling of digital therapeutics for the prevention, treatment, and/or management of any disorder with a behavioral component. The key products and services to be delivered...
This federal Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) totaling $1,076,018 aims to conduct a decentralized clinical trial of a contingency management digital therapeutic to treat stimulant use disorder (STUD). The funded project will develop and evaluate DCH-003, a prescription digital therapeutic that delivers contingency management and other evidence-based treatments for STUD through a mobile app. The...
This $512,256 Project Grant from the National Institutes of Health's National Institute on Drug Abuse will support Health Outcomes Inc. doing business as Telesage to develop a Primary Care-SUD Intake System (P-SUD-IS). The P-SUD-IS aims to address underdiagnosis of substance use disorders (SUDs) by streamlining the SUD assessment process for primary care clinicians. Telesage will create a HIPAA-compliant, automated, cloud-based system to facilitate completion of biopsychosocial assessments for...
This Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Use and Addiction Research Programs (CFDA 93.279) totals $680,046 and aims to study how social functioning changes during opioid use disorder (OUD) treatment. The study will integrate patient-reported and concerned significant other (CSO)-reported data on social behaviors, social reward, and social connection using ecological momentary assessment (EMA) methods and a smartwatch-based application called...
This federal Project Grant award from the National Institute on Drug Abuse (CFDA 93.279 - Drug Use and Addiction Research Programs) provides $355,414 to Yale University to implement and evaluate a digital therapeutic for addressing substance use disorders (SUDs), including opioid use disorder (OUD), among incarcerated individuals. The key objectives are to: 1) Assess the attitudes, perceptions, and implementation barriers/facilitators of using a digital cognitive-behavioral therapy (CBT4CBT)...
This Project Grant award from the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), provides $400,000 to develop and evaluate a customized version of the "MYTRIALS" integrated remote biomarker capture system to support decentralized clinical trials for substance use disorders (SUDs). The key objectives are to refine the existing MYTRIALS prototype to better meet the needs of SUD decentralized trials, and then conduct a...
This Project Grant award, with a total funding amount of $958,629, was awarded by the National Institute on Drug Abuse (NIDA) under the Drug Abuse and Addiction Research Programs (CFDA 93.279). The funding will support the real-world adoption of an innovative digital health therapeutic called KIOS, which uses nonlinear control theory to track multiple symptoms (e.g., craving, mood, pain) and deliver personalized, evidence-based intervention strategies to patients with opioid use disorder...
This $1,309,500 Project Grant awarded by the National Institutes of Health (NIH) under the Trans-NIH Research Support (CFDA 93.310) program supports the development of a novel digital psychiatry diagnostic framework that utilizes crowdsourcing algorithms to improve the specificity of machine learning models in distinguishing between autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in adolescents. The key products and services to be delivered under this 3-year...
This federal Project Grant award of $683,611 from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)'s Alcohol Research Programs (CFDA 93.273) is aimed at optimizing the engagement and clinical outcomes of a "smart" digital therapeutic for alcohol use disorder (AUD). The key products and services to be delivered through this funding include: Embedding a machine learning-based lapse prediction model into an existing digital therapeutic (A-CHESS) to provide personalized,...
This $613,356 Project Grant awarded by the National Institute on Drug Abuse (NIDA), under the Drug Use and Addiction Research Programs (CFDA 93.279), aims to develop and initially test a digital training tool called LEAPLINK. The tool will help service providers in housing, clinical, and social settings apply the evidence-based Life Enhancing Advocacy Program (LEAP) to better support people with lived experience of homelessness and substance use disorder. The key product developed through this...
SOCIALIZING A SCIENCE-BASED DIGITAL THERAPEUTIC FOR SUBSTANCE USE DISORDERS - PROJECT SUMMARY/ABSTRACT DIGITAL THERAPEUTICS ARE REDEFINING THE FUTURE OF MEDICINE. DIGITAL THERAPEUTICS REFER TO SOFTWARE USED TO PREVENT, TREAT, OR MANAGE A MEDICAL DISORDER OR DISEASE. DIGITAL THERAPEUTICS PACKAGE AN ENTIRE MODEL OF CARE - THAT CAN BE DELIVERED WITH FIDELITY AND IN ACCORDANCE WITH STATE-OF-THE-SCIENCE BEST PRACTICES - INTO A UNIFIED, SEAMLESS DIGITAL DELIVERY SYSTEM. THESE TOOLS ENABLE ANYTIME AND ANYWHERE HEALTHCARE. THE APPLICANT TEAM OF THIS PHASE 2 SBIR PROPOSAL DEVELOPED THE THERAPEUTIC EDUCATION SYSTEM (TES), WHICH BECAME THE VERY FIRST FOOD AND DRUG ADMINISTRATION (FDA)-AUTHORIZED "PRESCRIPTION DIGITAL THERAPEUTIC" IN THE U.S. TES IS ARGUABLY THE MOST EMPIRICALLY-SUPPORTED, DIGITAL INTERVENTION FOR SUBSTANCE USE DISORDER (SUD) TREATMENT. OUR TEAM HAS ALSO LED OVER TWO DECADES OF NIH-FUNDED WORK DEVELOPING AND EVALUATING DIGITAL THERAPEUTICS FOR MULTIPLE POPULATIONS - INCLUDING PERSONS LIVING WITH CHRONIC PAIN, DEPRESSION, HEAVY SMOKING, AND/OR BINGE EATING PROBLEMS. WE HAVE DEVELOPED A UNIQUE MOBILE PLATFORM (LADDR) WHICH INTEGRATES SCIENCE-BASED, THERAPEUTIC PROCESSES TO ADDRESS A WIDE RANGE OF BEHAVIORAL PROBLEMS IN THE CONTEXT OF A SINGLE MOBILE PLATFORM. LADDR INCLUDES THE SCIENCE BEHIND TES, BUT THIS PLATFORM PROVIDES A SCALABLE MODEL FOR DELIVERING DIGITAL THERAPEUTICS TO TREAT ANY DISORDER WITH A BEHAVIORAL COMPONENT. IN THIS SBIR PROJECT, WE PROPOSE TO "GO SOCIAL" WITH LADDR BY EXPANDING LADDR TO ALLOW ITS USERS TO ENGAGE A NON DRUG-USING SUPPORT NETWORK OF THEIR CHOOSING IN THEIR JOURNEY OF BEHAVIOR CHANGE. INTERVENTIONS THAT LEVERAGE SOCIAL SUPPORT CAN HELP KEEP INDIVIDUALS ENGAGED IN TREATMENT, REINFORCE THEIR SUCCESSES, AND HELP THEM TROUBLESHOOT CHALLENGES. HOWEVER, PRIOR ATTEMPTS TO IMPLEMENT SOCIAL SUPPORT INTO SUD TREATMENT HAVE BEEN CHALLENGED BY: (1) REQUIRING SUPPORT PERSONS TO COME TO SUD TREATMENT SITES IN PERSON, (2) NOT SHARING ACTIONABLE INFORMATION WITH SUPPORT PERSONS IN A TIMELY MANNER AND (3) NOT PROVIDING A STRUCTURE OR PROCESS FOR SUPPORT PERSONS TO PROVIDE EFFECTIVE SUPPORT. LADDR WILL ADDRESS ALL OF THESE CHALLENGES BY ALLOWING INDIVIDUALS TO SHARE DATA FROM LADDR IN REAL TIME ABOUT THEIR SUCCESSES AND CHALLENGES, AND THEIR SUPPORTER CAN OFFER ANYTIME/ANYWHERE SOCIAL SUPPORT. SOCIAL SUPPORT WILL BE EMBEDDED WITHIN A STRONGLY SCIENCE-BASED DIGITAL THERAPEUTIC PROCESS - THUS PROVIDING SUPPORT PERSONS WITH A CLEAR FRAMEWORK IN WHICH TO OFFER SUPPORT. WE WILL FOCUS ON THE TES-BASED SUD COMPONENT OF LADDR IN THIS PROJECT AND CAN LATER EXPAND THIS SOCIAL FUNCTIONALITY TO OTHER HEALTH DOMAINS WITHIN LADDR. IN PHASE I OF THIS PROJECT, WE DEVELOPED AND DEMONSTRATED THE TECHNICAL MERIT AND FEASIBILITY OF A VERSION OF LADDR THAT INCLUDES NOVEL SOCIAL SUPPORT FUNCTIONALITY. IN PHASE 2, WE PROPOSE TO COMPLETE THE DEVELOPMENT OF THE SOCIAL VERSION OF LADDR BASED ON FEEDBACK FROM PHASE 1 AND EVALUATE THE EFFECTIVENESS OF THE SOCIAL VERSION OF LADDR IN IMPROVING SUD TREATMENT OUTCOMES. TO OUR KNOWLEDGE, THIS PROJECT WILL BE THE FIRST TO SOCIALIZE SCIENCE-BASED DIGITAL THERAPEUTICS.