# Re-Engineering Systems to Treat Opioid use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial

> **NIH NIH DP1** · SAN DIEGO STATE UNIVERSITY · 2024 · $1,053,500

## Abstract

I am a well-published, early stage medical sociologist proposing to investigate the feasibility, acceptability, and preliminary efficacy of an innovative, multilevel community-engaged opioid use disorder (OUD) treatment intervention. This study will apply my understanding of community needs and OUD, to test a scalable novel intervention in a real world setting, leveraging my role as a leader in this field to disseminate findings and improve treatment access nationwide. Significant federal funding has expanded access to OUD treatment services in community health clinics (CHCs) that provide care to medically underserved populations and areas but barriers to accessing care persist. I propose to prepare for a fully powered clinical trial by testing whether a combined organization and patient-level intervention (Re-Engineering Systems to Treat Opioid Use Disorder for Everyone – RESTORE) that targets patient-, provider-, and system-level barriers to OUD treatment is feasible and acceptable in the context of CHCs. Community engagement will be continuous, exemplified by the use of peer navigators to connect patients to care and treatment. RESTORE will be based in Southern and Northern California—epicenters of the nation’s opioid crisis. Project Phases, guided by cutting edge implementation science, include 1) a qualitative investigation into provider and patient barriers to and facilitators of CHCs’ provision of buprenorphine treatment for OUD; 2) the operationalization of RESTORE into routine care, using preliminary findings from Phase I; and 3) a pilot stepped-wedge randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of RESTORE, as well as the protocols, procedures and training in CHCs. This study has the potential to improve effective treatment rates in CHCs and provide an evidence-based intervention to be tested at scale across multiple states in the U.S., thereby increasing treatment access, improving patient outcomes, and saving lives.

## Key facts

- **NIH application ID:** 10917290
- **Project number:** 5DP1DA058978-02
- **Recipient organization:** SAN DIEGO STATE UNIVERSITY
- **Principal Investigator:** Sabrina Lynn Smiley
- **Activity code:** DP1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,053,500
- **Award type:** 5
- **Project period:** 2023-09-01 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10917290

## Citation

> US National Institutes of Health, RePORTER application 10917290, Re-Engineering Systems to Treat Opioid use Disorder for Everyone (RESTORE): A Pilot Randomized Controlled Trial (5DP1DA058978-02). Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/grant/nih/10917290. Licensed CC0.

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