Developing a patient-centered FDA-Qualified Measure for Opioid Withdrawal
Official title: Developing an FDA-Qualified Clinical Outcomes Assessment for Opioid Withdrawal
Funded at City College of New York · NIH-11345702 · Data updated 2026-11-12
A patient-focused project to create and validate a reliable tool for measuring opioid withdrawal so medicines and treatments can be better tested and approved.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | City College of New York NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | June 15, 2025 |
| Project end | May 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $775,439 |
| NIH project number | 5UG3DA062907-02 |
| Project ID | NIH-11345702 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with opioid use disorder or people undergoing withdrawal who may participate in validation studies and focus groups.
✕Less likely to help
Individuals not experiencing opioid withdrawal or not involved in study activities may not benefit directly.
What this research studies
This project will build a consensus, patient-informed tool to measure opioid withdrawal symptoms, guided by FDA expectations. Researchers will adapt and expand the Short Opiate Withdrawal Scale by adding diverse patient input and clear rating anchors. They will gather data through focus groups and interviews with people who have lived experience with opioid use disorder to ensure the tool reflects real-world withdrawal experiences. The work progresses in four aims, starting with expanding the withdrawal domains and refining the measure based on participant feedback. The goal is a robust COA that can be used in clinical trials to evaluate medications and interventions for opioid withdrawal.
Why it matters
Potential benefit: If successful, patients could benefit from more accurate and meaningful measurement of withdrawal in trials and treatments.
How similar studies have gone: Previous scales like SOWS-Gossop informed withdrawal treatment approvals but lacked breadth and patient-centered anchors, so this project aims to improve on that with patient input.
Where this research is happening
-
City College of New York
New York, United States Active
Researchers
- Principal investigator: Brandt, Laura — City College of New York
- Study coordinator: Brandt, Laura
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.