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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT05935761
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chronic Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregnenolone — DRUG
    Pregnenolone dosing will begin at 500mg/day x 7 days, and will increase by 500mg each following week as tolerated (to a potential maximum dose 2000mg/day).
  • DHEA — DRUG
    DHEA dosing will begin at 100mg/day x 7 days, and will increase by 100mg each following week as tolerated (to a potential maximum dose 400mg/day).
  • Placebo — DRUG
    Same as active comparator arms, except placebo dispensed

Study Details

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 Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pregnenolone
    Pregnenolone dosing will begin at 500mg/day x 7 days, and will increase by 500mg each following week as tolerated (to a potential maximum dose 2000mg/day).
  • Active Comparator: DHEA
    DHEA dosing will begin at 100mg/day x 7 days, and will increase by 100mg each following week as tolerated (to a potential maximum dose 400mg/day).
  • Placebo Comparator: Placebo
    Same as active comparator arms, except placebo dispensed

Primary Outcome Measure

Pain Numerical Rating Scale (0-10) Change [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Jennifer C Naylor, PhD
[email protected]
(919) 286-0411
Christine E. Marx, MD MA (PRINCIPAL_INVESTIGATOR)
Jennifer C Naylor, PhD (PRINCIPAL_INVESTIGATOR)

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