Investigating Pregnenolone and DHEA for Chronic Low Back Pain in Veterans
This study is looking for U.S. Military Veterans, aged 18-65, who experience chronic low back pain. Researchers are testing two drugs, Pregnenolone and DHEA, against a placebo (an inactive substance) to see if they can reduce pain. You would receive one of these treatments, with the dose potentially increasing over several weeks. The main goal is to measure changes in your pain levels using a pain scale over six weeks. This study aims to find new, non-addictive treatments for chronic pain, which is a common issue for Veterans. The current status of this study is unclear, but it plans to enroll 108 participants.
- Study design
- This is a randomized controlled adaptive Phase II trial, meaning participants are randomly assigned to receive Pregnenolone, DHEA, or a placebo. It plans to enroll 108 participants.
- What's involved
- You would have weekly visits for six weeks, where your pain levels would be measured. Dosing of the study drug would start low and may increase weekly as tolerated.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain levels will be measured weekly for six weeks after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05935761
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
Not Yet Recruiting
PHASE2Ages 18–65InterventionalTreatmentVA Office of Research and DevelopmentGovernment-funded
~108 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:PregnenoloneDHEAPlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Numerical Rating Scale (0-10) Change
Measured over Visit 1 (Week 1/screening), Visit 2 (Week 2/Randomization/Baseline), Visit 3 (Week 3), Visit 4 (Week 4), Visit 5 (Week 5), Visit 6 (Week 6)
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Jennifer C Naylor, PhD · PRINCIPAL_INVESTIGATOR · Durham VA Medical Center, Durham, NC
- Christine E. Marx, MD MA · PRINCIPAL_INVESTIGATOR · Durham VA Medical Center, Durham, NC
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Pain Numerical Rating Scale (0-10) ChangeVisit 1 (Week 1/screening), Visit 2 (Week 2/Randomization/Baseline), Visit 3 (Week 3), Visit 4 (Week 4), Visit 5 (Week 5), Visit 6 (Week 6)
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).