NCT05671692

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Christine Marx, MD · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Traumatic Brain Injury
• TBI

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-06
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2023-01-05
• Last updated: 2026-01-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study