Expanding the use of LUCEMYRA for treating opioid withdrawal in adolescents
Registration Development Program for LUCEMYRA (Lofexidine) Label Expansion for Opioid Withdrawal Treatment in Adolescents
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 ID | NIH-11003568 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Ideal candidates for this research are adolescents experiencing opioid withdrawal symptoms who require treatment.
Not a fit: Patients who are not experiencing opioid withdrawal or who are outside the adolescent age range may not benefit from this research.
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 performed: 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
Louisville, United States
- 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 below.