# Remotely Observed Methadone Evaluation (ROME)

> **NIH NIH R43** · SONARA HEALTH INC · 2022 · $267,861

## Abstract

Abstract –
Three million Americans and 16 million individuals worldwide have had or currently suffer from opioid use
disorder (OUD). OUD afflicts individuals from all socioeconomic and educational backgrounds with devastating
consequences, including a rising incidence of neonatal abstinence syndrome and the spread of infectious
diseases, i.e., HIV and hepatitis C, associated with syringe sharing. The most recent provisional data from the
Centers for Disease Control and Prevention (CDC) indicate that approximately 81,230 drug overdose deaths
occurred in the United States in the 12 months leading up to May 2020—the largest annual number of drug
overdoses ever recorded. In 2019, hospitals estimated an annual cost of OUD of $787B to society, $93B to
taxpayers, and $89B to the healthcare sector. Medications for opioid use disorder (e.g., methadone,
buprenorphine, or naltrexone) are central to the treatment of OUD. Methadone, a proven and effective opioid
medication for treating OUD, extends retention in care, reduces mortality, and inhibits illicit drug use. However,
methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet
complex regulatory requirements for certification. The regulations require new patients to take their dose in
person six days per week and limit the locations where patients may receive methadone. Finding an OTP can
be challenging, especially for those in rural areas as only 3% of OTPs are rurally located. The greatest barriers
that keep individuals with OUD from receiving treatment include 1) Availability; 2) Accessibility (i.e., daily visits
for directly observed dosing); 3) Acceptability (i.e., need for detox for other non-methadone treatment options);
and 4) Privacy. To address these barriers, Elpidatec has developed Elpida, an OTP-specific, mobile- and
desktop-friendly web-application that combines video, tamper-evident barcode labels, facial recognition,
and machine learning (ML) to enable accelerated take-home methadone regimens while maintaining
safety and diversion prevention. Elpida enhances patient access to treatment, aligns with OTP workflow, and
improves physician assessment and management of OUD patients, providing previously inaccessible patient
information via real-time, ecological momentary assessments (EMAs). In this project, Elpidatec will complete
feasibility testing, iterative product development, and market fit testing of Elpida in partnership with Adapt
Oregon, a rural OTP, and Oregon Health and Science University. The Phase I SBIR application has three aims:
1) Conduct feasibility testing of the minimum viable product (MVP) with patient- and clinician-facing web-
applications and evaluate tracking performance; 2) Develop and integrate key ML-enhanced features such as
facial recognition and methadone vial position tracking for automated dosing event interpretation; and 3) Assess
the demand and acceptability of Elpida among providers and patients. Insights gathere...

## Key facts

- **NIH application ID:** 10483876
- **Project number:** 1R43DA056259-01
- **Recipient organization:** SONARA HEALTH INC
- **Principal Investigator:** Steffani R Bailey
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $267,861
- **Award type:** 1
- **Project period:** 2022-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483876

## Citation

> US National Institutes of Health, RePORTER application 10483876, Remotely Observed Methadone Evaluation (ROME) (1R43DA056259-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10483876. Licensed CC0.

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