Currently there is no cost effective tool which enables researchers to study drug addiction relapse in real time. The standard remains to be urine analysis or self-report/surveys. Unfortunately, depending on the drug, urine analysis can only detect recent drug use in the previous 24 to 72 hours. Even in the best case scenario and based on lab assay results, the associated intervention response occurs 2-6 days after a relapse.
This Funding Opportunity Announcement (FOA) attempts to address this gap through the development of mobile health (mHealth) approaches such as recovery wearables and supporting mobile applications. Miniaturization and cost reduction of sensors have made it technologically feasible to capture digital biomarkers, defined as patient generated physiological and behavioral measures that are collected through digital tools, associated with reinitiating drug use and relapse. This has been explored for various indications including cocaine, smoking and stress by measuring various activities and including measures of breathing patterns, heart rate and perspiration. However, the wearables used in these studies had a number of limitations which must be overcome prior to FDA approval or product launch. Issues noted include being able to accurately and continuously capture data in natural environments, reduce the number of false negatives, increase technology acceptability, effectively address privacy issues, and define rigorous and standard methods for analysis, data validation and implementation.
Despite the growing interest in and increased importance of digital biomarkers, the available tools that patients and practitioners have to monitor and intervene are extremely limited. A number of wearable and mobile applications have been approved by the FDA. However, there are no FDA-approved wearables or supporting mobile application which can indicate reinitiating drug use and relapse in a patient with a substance use disorder.
The purpose of this initiative is to incentivize small businesses to develop next generation wearables and supporting mobile applications to identify digital biomarkers, and create a model for just-in-time intervention. Digital biomarkers may be early stage or validated. Applications proposing to develop stand-alone mobile applications will not be considered, for instance, mobile applications which rely soley on self-report as a predictive marker for potential drug use or relapse would be non-responsive and would be withdrawn before review.
Example of Potential Tools, Technologies, or Products. This initiative will support small business development of research-enabling tools, technologies, or products such as (but not limited to):
Phase I: Develop device and measure efficacy of biosensors
- Seek feedback from a panel of health care professionals who are potential end-users (e.g. therapists who are tracking patient progress in clinical practice) on what features and functions these professionals would most likely to see and most likely to convince them to employ this wearable relapse device and support software system.
- Ensure that the developed wearable devices and accompanying mobile applications balance the need for sensitive and robust sensors capable of detecting digital biomarkers, while also ensuring that the devices are appealing, in turn increasing probability of adoption, retention, and commercialization.
- Prototype design should factor in stigma associated with wearing monitoring devices (e.g. adding a time interface to make the device look like a smart watch may increase patient acceptability).
- The developed wearable and accompanying software system should be scalable and HIPAA, HITECH Act, and CFR 42 Part 2 (confidentiality of alcohol and drug abuse patient records) compliant.
- Develop a robust production model prototype and demonstrate its ability to detect relapse in real time in a natural environment, including the following:
- Collect quantitative and qualitative data on patient reactions to wearing the developed devices(s), including, but not limited to, engagement, functionality, usability, acceptability, physical reactions (e.g., itchiness from wearable sensor patch), interactivity, etc.
- Digital biomarker data must be collected in parallel and correlated with conventional bio specimen analysis (e.g., saliva, urine).
- Build in incentives for meeting treatment-plan-adherence goals.
- Testing for complete therapeutic outcomes is premature. However, for success, the system must produce change. Therefore, potential positive impact on the patient, which can include biological, psychological, and/or therapeutic outcomes, should be measurable, and related data will be critical in determining whether the project will move forward to Phase II.
Upon completion of Phase II activities, it is envisioned that the company will have a device which would be ready for testing with a suitable population to demonstrate data suitable for FDA consideration. The company should provide evidence of a likelihood to obtain additional capital commitment from the private sector or other non-SBIR funding sources to move the product toward the market.
See Section VIII. Other Information for award authorities and regulations.