RecruitingPhase 4NCT06852469

Computational Assessment of GABA Receptor Modulation in PTSD

Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder

Sponsor

VA Office of Research and Development

Enrollment

150 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Disorders, Post-Traumatic

Summary

A substantial majority of Veterans with posttraumatic stress disorder (PTSD) continue to suffer even with the best current medications. Progress in developing more effective medications is hampered by the substantial variability within Veterans with PTSD, meaning the most effective medication likely varies from individual to individual. New scientific tools to help identify distinct subgroups of Veterans with PTSD who are likely to respond to specific medications could help improve treatment in this population. Research has indicated that a specific subgroup of Veterans with PTSD with a high level of anxious arousal may benefit from medications which boost signaling of the neurotransmitter gamma-aminobutyric acid (GABA). This project aims to validate a clinical test to identify these individuals using new computational and neuroimaging methods combined with the medication lorazepam, a positive GABA modulator. The ultimate goal is to use these methods in future clinical trials of new medications to target the best treatments to individual Veterans with PTSD.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how a medication that calms brain activity (a low dose of lorazepam, a type of anti-anxiety medicine) affects brain function differently in veterans with PTSD compared to those without it. The goal is to better understand the brain chemistry of PTSD. **You may be eligible if:** - You are a veteran between 18 and 65 years old - You are willing to avoid alcohol for 24 hours before and after the study session - You are able to give informed consent - If applying for the PTSD group: you have a current PTSD diagnosis confirmed by a clinical interview **You may NOT be eligible if:** - You have uncontrolled neurological, cardiovascular, or other major medical conditions - You are pregnant or breastfeeding - You have a history of bipolar disorder type I or a chronic psychotic disorder - You currently use benzodiazepines or opioids - You have a moderate or severe substance use disorder - You have had a traumatic brain injury with loss of consciousness for more than 30 minutes - You have active suicidal thoughts - You are not right-handed (for the MRI portion of the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLorazepam 1 mg tablet

Lorazepam is an oral medication which is FDA approved to treat anxiety.

DRUGPlacebo tablet

Placebo will match the study drug in mode of administration, color, size, and taste.

Locations(1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

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NCT06852469

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