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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
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)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had lower back pain for at least 6 months.
Select...
I am female and my pregnancy test is negative.
Select...
My average daily pain score is at least 4 out of 10.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Numerical Rating Scale (0-10) Change
Secondary outcome measures
Brief Pain Inventory
Other outcome measures
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
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,325 Total Patients Enrolled
Jennifer C Naylor, PhDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
2 Previous Clinical Trials
174 Total Patients Enrolled
Christine E. Marx, MD MAPrincipal InvestigatorDurham VA Medical Center, Durham, NC
3 Previous Clinical Trials
386 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I understand and can participate in the consent process.You have strong thoughts about hurting yourself or others that require immediate help.I do not have any unstable illnesses like seizures or kidney problems.I am currently using oral contraceptives or hormonal supplements.You have been diagnosed with alcohol or drug abuse or dependence in the past three months according to the DSM-5 criteria.I do not have any serious health issues that could affect my participation in the study.I am using birth control as I could get pregnant during the study.I have had a traumatic brain injury that was not severe.I have been diagnosed with bipolar disorder, schizophrenia, or another similar condition.I have had lower back pain for at least 6 months.I use narcotic pain medication every day.I am female and my pregnancy test is negative.I have had a procedure to reduce back pain in the last 3 months.I am a veteran aged 18-65 with chronic low back pain.I don't expect to change my mental health or pain meds for 6 weeks.My average daily pain score is at least 4 out of 10.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: Pregnenolone
- Group 2: DHEA
- Group 3: Placebo
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for me to take part in this experiment?
"This clinical study is looking for 108 people suffering from chronic lower back pain, aged 18-65. Prospective participants must meet these requirements in order to be accepted."
Answered by AI
Can new participants still join this clinical experiment?
"From what is posted on clinicaltrials.gov, this medical experiment has ceased recruitment of patients. First launched on April 1st 2024 and last amended June 29th 2023, the trial no longer requires participants; however, 329 other studies are still actively seeking enrollees."
Answered by AI
Has the FDA sanctioned Pregnenolone for human usage?
"Pregnenolone received an assessment of 2 due to the evidence that supports its safety, though there is no existing data regarding its efficacy."
Answered by AI
Does this research study include adults above the age of twenty-five?
"In line with the inclusion criteria, this trial is only available to patients between 18 and 65 years of age. Alternatively, there are 9 studies for those below that threshold and 251 trials suited for participants over 65."
Answered by AI
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