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Novel Intervention for Chronic Complex TBI in OEF/OIF/OND Veterans

NCT05671692 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-05-13

No results posted yet for this study

Summary

The goal of this clinical trial is to compare pregnenolone and placebo (a placebo is a look-alike substance that contains no active drug) in Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)-Era Veterans with a history of chronic Traumatic Brain Injury (TBI). The main questions it aims to answer are:

* Does pregnenolone improve psychological health, overall physical function, cognition, symptoms of PTSD, and pain more than placebo over the 8-week study period, and what is the most effective dose of the drug that is safe and well-tolerated?
* What are the biological effects of pregnenolone, and how do pregnenolone and other molecules change over the course of treatment? (and do pregnenolone and other molecules predict clinical improvement?)

Participants who are eligible and consent to participate in the study will:

* be randomized in a 1:1 ratio to take pregnenolone or placebo
* be given pregnenolone or placebo to take each day at home
* will participate in 6 visits over 11 weeks for tests, exams and procedures that are for study purposes (each visit will last 1.5 - 3 hours)
* be evaluated at each visit to determine if there are any bad reactions to the study drug and if study participation is still appropriate
* be financially compensated for their visit time and travel cost

Conditions

Interventions

DRUG

Pregnenolone

Pregnenolone 250 mg BID x 14 DAYS, followed by Pregnenolone 500 mg BID x 14 DAYS, followed by Pregnenolone 1000 mg BID x thereafter for the remainder of the 8-week trial

DRUG

Placebo

Same as active comparator, except placebo dispensed.

Sponsors & Collaborators

  • Christine Marx, MD

    lead OTHER

Principal Investigators

  • Chris Marx, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2026-08-30
Completion
2026-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05671692 on ClinicalTrials.gov