VA Office of Research and Development
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.
Pain is one of the most common reasons that Americans seek medical care, with more than 50 million Americans reporting pain that is chronic (CDC NHIS data) and almost 20 million Americans reporting high impact pain that affects major life activities (Nahin, 2015). Chronic pain conditions disproportionately impact U.S. Military Veterans, and back pain is one of the most common diagnoses among Iraq/Afghanistan-era Veterans. The often-debilitating sequelae of chronic low back pain profoundly impacts quality of life and function in a very large number of Veterans and is substantial risk factor for…
Inclusion Criteria: * Veterans 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 accept…
Pregnenolone dosing will begin at 500 milligrams (mg)/day x 7 days, and will increase by 500mg each following week as tolerated (to a potential maximum dose 2000mg/day).
DHEA dosing will begin at 100 milligrams (mg)/day x 7 days, and will increase by 100mg each following week as tolerated (to a potential maximum dose 400mg/day).
Same as active comparator arms, except placebo dispensed
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