# Demonstration of a Digital Care Program for Methamphetamine Use Disorder

> **NIH NIH R43** · AFFECT THERAPEUTICS, INC. · 2021 · $309,360

## Abstract

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.

## Key facts

- **NIH application ID:** 10382485
- **Project number:** 1R43DA055394-01
- **Recipient organization:** AFFECT THERAPEUTICS, INC.
- **Principal Investigator:** Kristin Muhlner
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $309,360
- **Award type:** 1
- **Project period:** 2021-09-30 → 2022-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10382485

## Citation

> US National Institutes of Health, RePORTER application 10382485, Demonstration of a Digital Care Program for Methamphetamine Use Disorder (1R43DA055394-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10382485. Licensed CC0.

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