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NCT05935761 · ClinicalTrials.gov registry record · Phase 2
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
A Phase 2 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT05935761: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT05935761 is a Phase 2 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05935761, a Phase 2 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
Chronic pain symptoms are very common among U.S. Military Veterans and have a profound negative impact on mental health symptoms and quality of life, in addition to increasing risk for suicidal ideation and suicidal behaviors. There are currently extremely few safe and effective pharmacological treatments for chronic pain disorders, and the clinical need to develop new therapeutics for pain has never been more urgent. Fueled by the worsening opioid crisis and further exacerbated by the COVID-19 pandemic, opioid and other drug overdose deaths have climbed to staggeringly high levels. The rapid development of medications for the management of chronic pain conditions that are safe, well-tolerated, efficacious and non-addicting is thus of paramount importance. The two neurosteroid candidates to be investigated in this trial are naturally occurring molecules enriched in human brain and potentially ideal candidates for safe and effective chronic pain treatment.
Primary Outcome
Weekly mean of the 24-hour average pain severity scores recorded daily on an 11-point numerical rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Interventions
- DRUG Placebo
- DRUG Pregnenolone
- DRUG DHEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What is known before NCT05935761 opens enrollment
NCT05935761 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05935761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05935761 about?
NCT05935761 is a clinical study titled "Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial". Chronic pain symptoms are very common among U.S. Military Veterans and have a profound negative impact on mental health symptoms and quality of life, in addition to increasing risk for suicidal ideation and suicidal behaviors. There are currently extremely few safe and effective pharmacological trea...
What is the current status of trial NCT05935761?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2026-09-01. Estimated completion is 2029-12-31.
What interventions are being tested in trial NCT05935761?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG), DHEA (DRUG).
Who is sponsoring clinical trial NCT05935761?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05935761's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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