Using lofexidine to treat infants with opioid withdrawal symptoms
Official title: Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome
Funded at Uswm, LLC · NIH-10320676 · Data updated 2026-11-12
This study is testing a medication called lofexidine to see if it can help babies who are going through withdrawal from opioids, with the hope of making their treatment safer and more effective.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Uswm, LLC NIH-funded |
| Lab location | 1 site (Louisville, United States) |
| Project start | September 30, 2021 |
| Project end | August 31, 2025 |
| Funding year | 2021 |
| Award (this year) | $5,353,314 |
| NIH project number | 1UG3DA054799-01 |
| Project ID | NIH-10320676 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are newborns diagnosed with Neonatal Opioid Withdrawal Syndrome.
✕Less likely to help
Patients who are not newborns or do not have a diagnosis of opioid withdrawal syndrome will not benefit from this research.
What this research studies
This research focuses on developing lofexidine as a safe and effective treatment for Neonatal Opioid Withdrawal Syndrome (NOWS) in infants. Currently, there are no FDA-approved medications for this condition, and existing treatments often involve off-label opioid use, which can prolong hospital stays and increase healthcare costs. The study aims to evaluate the efficacy of lofexidine, which has been previously approved for adults, in alleviating withdrawal symptoms in newborns. By doing so, the research seeks to improve the care and outcomes for infants affected by opioid withdrawal.
Why it matters
Potential benefit: If successful, this research could provide a much-needed FDA-approved treatment option for infants suffering from opioid withdrawal, potentially reducing hospital stays and healthcare costs.
How similar studies have gone: Previous research has shown success in using lofexidine for adults with opioid withdrawal, indicating potential for similar outcomes in neonates, although this specific application is novel.
Where this research is happening
-
Uswm, LLC
Louisville, United States Active
Researchers
- Principal investigator: Gullo, Kristen Leann — Uswm, LLC
- Study coordinator: Gullo, Kristen Leann
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.