Project Summary / Abstract This application responds to PA 20-262 for Small Business Innovation Research, Phase I, addressing SBA- approved NIDA-specified Area 2, Topic D: “Digital health therapeutics (e.g., Software as Medical Device, Software in Medical Device) focused on behavioral health interventions to alleviate the burden of SUD.” The applicants (Affect Technologies, Inc.), propose to examine and confirm the technical merit and real-world feasibility of the Affect app as the core component of the Affect digital care program for treatment of methamphetamine use disorder (MUD). The project includes a clinical trial that will assemble data on the functionality of the app in engaging patients and delivering treatment components and services, using outputs to guide rapid refinements of the app’s functions (e.g., active and passive data collection, patient inference engine, triggers for clinician actions, and user interfaces). The project will analyze these and other aspects of the app to characterize their relationships with patient engagement, participation, and retention. Quantitative data on app feasibility/usability will include app usage statistics, and data on program impacts on outcomes will consist of results of saliva drug tests of individuals with MUD as participants in the Phase I research (N=90). Qualitative data on the clinical utility (acceptability and satisfaction) of the Affect app and program will be collected via all-virtual focus groups and app-enabled rating scales and questionnaires eliciting feedback from participants, clinicians, and stakeholders. Results will determine technical merit/feasibility and will inform refinements to the app and program correlated with outcomes, including methamphetamine use. Specific aims are to: Aim 1. Confirm the technical merit and feasibility of the Affect app and its delivery of the Affect digital care program in real-world practice based on results from the clinical trial; Aim 2. Identify components of the Affect app and the Affect digital care program that correlate with patient engagement, participation, retention, and changes in methamphetamine use; and Aim 3. Use results to iteratively refine the Affect app and care program to improve treatment of MUD toward substantiating commercialization. Demonstrating the clinical utility of the Affect digital care platform leading to better patient outcomes could improve clinical care for the 1.6 million people in the nation who need treatment for MUD, and it would increase access to serve the million users who never receive treatment. If shown to be feasible and effective in retaining participants in treatment, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost.

Project Narrative Demonstrating the technical merit/feasibility of the Affect app in delivering digital care for methamphetamine use disorder (MUD) would potentially improve clinical care for the 1.6 million people in the nation who need treatment for MUD. If shown to be clinically useful, well-received by patients, and effective in retaining participants in the care program, the Affect app will be an important element in efficiently achieving optimum patient outcomes at reasonable cost. Resulting knowledge will be useful to clinicians, technology developers, and researchers when disseminated in publications, offering new insights into innovative means to help individuals with MUD reduce methamphetamine use and succeed in recovery.