Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Control… (NCT05935761) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
United States108 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veterans, 18-65 years of age with chronic low back pain.
* Based on medical history and medical records, have low back pain (Thoracic Vertebrae 6 or below) present on most days for the preceding 6 months or longer, and fulfill all disease diagnostic criteria (please see disease diagnostic criteria below).
* Have a weekly mean of 24-hour average pain score 4 at baseline.
* Negative pregnancy test if female. Sexually active subjects are required to use a medically acceptable form of birth control if they are of childbearing potential and could become pregnant during the study. A medically acceptable form of birth control includes non-hormonal intrauterine devices, surgical sterilization, or double barrier methods (e.g. diaphragm with contraceptive jelly, condom with contraceptive foam, cervical caps with contraceptive jelly). Sexual abstinence with agreement to continue abstinence or to use a medically acceptable method of contraception (as listed above) should sexual activity occur is permissible.
* No change in medications less than 4 weeks before baseline.
* No anticipated need to alter psychotropic or pain medications for the 6-wk study duration (as determined by study physician's review of records and/or discussion with prescribing physician).
* Ability to fully participate in the informed consent process.
Exclusion Criteria:
* Unstable medical or neurological illness, including seizures, renal impairment or cerebral vascular accident (CVA).
* Use …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a Phase II study — what does that mean for how much is already known about the safety and effectiveness of these interventions for chronic low back pain, and how does that affect whether it might be right for me?
2The trial is listed as 'not yet recruiting' — do you know when it's expected to open, and is there anything I should be doing now, like standard treatments, while I wait to see if I'd be eligible?
3The main thing this trial is measuring is change in pain on a 0-to-10 scale — do you think that kind of pain reduction would be meaningful for my specific situation, and are there other aspects of my back pain, like function or sleep, that this trial may not be focused on?
4Since this trial is specifically for US military veterans, do you know whether my service history and current care setting would even allow me to be considered, and who would I contact to find out more?
5Before looking at an experimental trial like this, are there established treatments for chronic low back pain that I haven't tried yet that you'd recommend I consider first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.