Expanding the use of LUCEMYRA for treating opioid withdrawal in adolescents
Official title: Registration Development Program for LUCEMYRA (Lofexidine) Label Expansion for Opioid Withdrawal Treatment in Adolescents
Funded at Uswm, LLC · NIH-11003568 · Data updated 2026-11-12
This study is looking at how LUCEMYRA can help teenagers who are going through opioid withdrawal, making sure they have a safe and effective way to get the support they need during this tough time.
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 | July 15, 2024 |
| Project end | June 30, 2026 |
| Funding year | 2024 |
| Award (this year) | $2,916,742 |
| NIH project number | 1UG3DA061620-01 |
| Project ID | NIH-11003568 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are adolescents experiencing opioid withdrawal symptoms who require treatment.
✕Less likely to help
Patients who are not experiencing opioid withdrawal or who are outside the adolescent age range may not benefit from this research.
What this research studies
This research aims to develop and expand the use of LUCEMYRA (lofexidine) for treating opioid withdrawal symptoms specifically in adolescents. It addresses the significant public health crisis of increasing opioid use disorder among young people, who often face barriers to accessing effective treatment. The project involves collaboration with the FDA to meet regulatory requirements for the approval of lofexidine in this age group, ensuring that adolescents have access to safe and effective treatment options. By focusing on this underserved population, the research seeks to improve initial engagement in treatment and facilitate transitions to longer-term care.
Why it matters
Potential benefit: If successful, this research could provide adolescents with a safe and effective treatment option for opioid withdrawal, potentially reducing the risk of overdose and improving their chances of recovery.
How similar studies have gone: Previous research has shown success in using lofexidine for opioid withdrawal in adults, but this specific application for adolescents is novel.
Where this research is happening
-
Uswm, LLC
Louisville, United States Active
Researchers
- Principal investigator: Schmidt, Lee — Uswm, LLC
- Study coordinator: Schmidt, Lee
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.