Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

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.

Key facts

Study ID

NCT05935761

Run by

VA Office of Research and Development

People needed

108

Starts

2026-09-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Unstable medical or neurological illness, including seizures, renal impairment or cerebral vascular accident (CVA).
• Use of oral contraceptives or other hormonal supplements-this is out of caution, as it is unknown if the study medications would impact the efficacy of hormonal contraception.
• Significant suicidal or homicidal ideation that necessitates intervention.
• Daily use of long or short-acting narcotic medications (PRN use will be considered).
• Current DSM-5 diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder, or cognitive disorder due to a general medical condition.
• Female participants who are pregnant or breast-feeding.
• Known allergy to study medication.
• History of moderate or severe TBI (mild TBI is permissible).
• DSM-5 criteria met for alcohol and/or other substance abuse or dependence within past three months (excludes caffeine and nicotine).
• Have received epidural steroids, facet block, nerve block or other invasive procedures aimed to reduce low back pain within the past 3 months prior to Visit 1.
• Have ongoing or anticipated disability compensation or litigation issues, in the best judgment of the investigator.
• Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures, such as treatment-refractory history.
• Have serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator and study physician, would compromise participation or be likely to lead to hospitalization during the study.

Where it is running

• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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