Two neurosteroid medicines being tested for chronic low back pain in U.S. veterans
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
['FUNDING_OTHER'] · DURHAM VA MEDICAL CENTER · NIH-11249118
This project will compare two experimental neurosteroid medicines against a placebo to see if they safely ease chronic low back pain in U.S. military veterans.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | DURHAM VA MEDICAL CENTER (nih funded) |
| Locations | 1 site (DURHAM, UNITED STATES) |
| Trial ID | NIH-11249118 on ClinicalTrials.gov |
What this research studies
You would be randomly assigned to one of three groups: one neurosteroid, the other neurosteroid, or a placebo, and neither you nor the staff would know which you get. The trial is double-blind and uses an adaptive design that can adjust group assignments as results come in to focus on the best options. Doctors will monitor your pain levels, side effects, and overall safety over the treatment period and collect health information and possibly blood samples. The work builds on earlier findings that one neurosteroid (pregnenolone) helped chronic low back pain and that another (DHEA) shows promise.
Who could benefit from this research
Good fit: Ideal candidates are U.S. military veterans with persistent chronic low back pain who meet the trial's medical and safety criteria and can attend clinic visits at the study site.
Not a fit: People without chronic low back pain, with pain caused by conditions not targeted in the trial, or with medical contraindications to neurosteroids may not benefit from this research.
Why it matters
Potential benefit: If successful, this could offer veterans a safer, non-addictive medication option to reduce chronic low back pain.
How similar studies have performed: Prior randomized work reported that pregnenolone at a high dose reduced chronic low back pain, and early data for DHEA are promising, but larger trials are still needed.
Where this research is happening
DURHAM, UNITED STATES
- DURHAM VA MEDICAL CENTER — DURHAM, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: NAYLOR, JENNIFER C — DURHAM VA MEDICAL CENTER
- Study coordinator: NAYLOR, JENNIFER C
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.