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Neurosteroid

Pregnenolone + DHEA for Lower Back Pain

Phase 2

Waitlist Available

Led By Jennifer C Naylor, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Negative pregnancy test if female

Must not have

Female participants who are pregnant or breast-feeding

Current DSM-5 diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder, or cognitive disorder due to a general medical condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Summary

This trial will investigate if two new medications can help U.S. Military Veterans with chronic pain, reducing the risk of opioid addiction and overdose.

Who is the study for?

This trial is for US Military Veterans aged 18-65 with chronic low back pain lasting at least 6 months, who have not changed their medications in the last 4 weeks and can commit to not altering them during the study. Participants must use birth control if applicable and cannot be pregnant or breastfeeding. Those with unstable medical conditions, recent substance abuse, or certain psychiatric diagnoses are excluded.

What is being tested?

The trial is testing Pregnenolone and DHEA—naturally occurring neurosteroids—against a placebo to see if they safely relieve chronic lower back pain without addiction risks. It's an adaptive Phase II study where participants are randomly assigned to one of these treatments.

What are the potential side effects?

Potential side effects of Pregnenolone and DHEA may include hormonal imbalances like acne or hair loss, mood changes such as irritability or anxiety, sleep disturbances, headaches, and possibly upset stomach. The exact side effect profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had lower back pain for at least 6 months.

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I am female and my pregnancy test is negative.

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My average daily pain score is at least 4 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have been diagnosed with bipolar disorder, schizophrenia, or another similar condition.

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I do not have any unstable illnesses like seizures or kidney problems.

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I am currently using oral contraceptives or hormonal supplements.

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I use narcotic pain medication every day.

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I have had a traumatic brain injury that was not severe.

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I have had a procedure to reduce back pain in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Numerical Rating Scale (0-10) Change

Secondary study objectives

Brief Pain Inventory

Other study objectives

Beck Depression Inventory, 2nd Edition

PTSD-Checklist 5

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: PregnenoloneActive Control1 Intervention

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).

Group II: DHEAActive Control1 Intervention

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).

Group III: PlaceboPlacebo Group1 Intervention

Same as active comparator arms, except placebo dispensed

0 / 10Eligibility criteria met