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.
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 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
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)
Parallel
Pregnenolone
DrugPregnenolone 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
DrugDHEA 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).
Placebo
DrugSame as active comparator arms, except placebo dispensed
Pain Numerical Rating Scale (0-10) Change
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).
Brief Pain Inventory (BPI)
The BPI is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Questions from the BPI will be asked at each study visit.
Beck Depression Inventory, 2nd Edition (BDI-II)
The BDI-II is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
Post-traumatic stress disorder (PTSD)-Checklist 5
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Scores of 31-33 or higher suggests potential benefit from PTSD treatment. Scores lower than 31-33 may indicate the patient either has subthreshold symptoms of PTSD or does not meet criteria for PTSD.
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