Subject of the Challenge

Background

The problem of drug abuse affects almost every community and family and yet it remains an uncomfortable subject for discussion. Each year, substance abuse causes high rates of injuries and mortality among Americans and plays a role in many major social problems, such as drugged driving, violence, child abuse, stress, crime, and problems with employment. It harms unborn babies, destroys families, and contributes to homelessness. The societal burden caused by substance use disorders exceeds half a trillion dollars yearly. This cost to society is greater than other chronic conditions such as diabetes ($131.7 billion) and cancer ($171.6 billion). NIDA sponsors the majority of addiction-related scientific research in the world. NIDA-funded researchers seek to answer important scientific questions about the paths people take to avoid or to succumb to drug addiction, about the mechanisms and pathways involved in substance-use disorders, and about new tools and techniques for prevention and treatment.

Because the problems stemming from drug abuse and addiction affect almost every community and family to some degree, NIDA issues this Challenge with the hope that Contestants will actively mobilize around the need to know more about the roots of drug abuse and addiction. Specifically, NIDA is seeking to engage communities to envision and to create an app which will help advance scientific research in areas of nicotine, opioids, cannabinoids (including marijuana), methamphetamines, and prescription drug use. The Institute is also interested in further understanding abstinence and wellness as it relates to drug addiction.

The causes and consequences of addiction are multi-faceted, involving biological, behavioral, social, cultural, economic, and environmental factors. These factors likely interact, with no single factor exerting substantial independent influence on drug use and addiction risk. Unfortunately, most research addresses these factors separately because it is difficult to collect data on the large numbers of participants needed to understand the multi-factor relationships. However, this is changing. Mobile technology offers the capacity to recruit large numbers of participants, in diverse and distant places and to collect prospective data on a broad range of variables as these study participants go about their daily lives. This approach has already led to advances in addiction research. Mobile assessment has extended to geolocation and physiological monitoring, with promising results for predicting and detecting drug use in the field.

As exciting as these findings have been, however, the scope of studies and the types and number of participants studied have been limited by researchers’ access to mobile technology. The problem has been exacerbated by a gap in communication between addiction researchers and software and hardware developers. In addition, NIDA-sponsored mobile tools and technologies are often afflicted by a lack of interoperability and by non-sustainability beyond the grant-funding period.

Fortunately, those concerns can be successfully addressed by the inventive uses of customizable research platforms developed by the established informatics technology companies. The recently unveiled ResearchKit developed by Apple Inc. is the available platform designed specifically for biomedical research (https://www.apple.com/researchkit/). NIDA’s choice of ResearchKit as the platform does not reflect any endorsement of Apple Inc. and Apple’s products in the Challenge; rather, it is a response to Apple’s release of a set of tools specifically intended for use in health research.

Challenge Goals

NIDA hopes this Challenge will help to promote the development of innovative research apps created on Apple’s ResearchKit framework for future addiction studies. Research questions to be answered could include, but are not limited to: Would tracking lifestyle choices, behaviors, nutrition, stress, social participation, work, school, home, neighborhood, genetics, exposure to technology, etc. help to understand why some people manage to stay away from drug abuse and addiction? What contributes to the choice to abuse prescription drugs? How can we systematically collect the experience of patients recovering from addiction? Are there innovative approaches to recording patients’ experiences of impact and burden of drug addiction over time? Can the benefits of reduced drug use be meaningfully detected? Can we reveal and collect the participant-identified disease impacts and the preferences for treatment impacts to identify meaningful, significant, perhaps, novel, and potential measures of benefit?

It is critical to note that the apps developed as a result of this Challenge are to be explicitly created for future scientific research purposes, and not for self-help, education, or self-wellness monitoring like other apps already available on iTunes. The submissions must not contain any data about real people, and the Contestants must not use data from or about real people in the development or testing of the apps. However, the app should be designed such that it could be used in future clinical research studies with real human subjects.

Major ethical and legal issues that have to be addressed at every step of the way should include privacy (especially in terms of the end-user’s experience as he or she interacts with the app) and confidentiality (the assurance that end-users’ data will be seen and used only in the ways they want). Contestants are responsible for developing and coding the app so that its future use in a study with real human research subjects would be compliant with all applicable federal, state, local, and institutional laws, regulations, and policies. These include, but are not limited to, Substance Abuse Confidentiality Regulations at 42 CFR Part 2, Health Information Portability and Accountability Act (HIPAA) protections, Department of Health and Human Services (HHS) Protection of Human Subjects regulations at 45 CFR Part 46, and Food and Drug Administration (FDA) regulations.

For more information, please see Data Security and Regulatory Requirements Policies.

For official challenge information, please see the Federal Register Notice.