Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06852469

Computational Assessment of GABA Receptor Modulation in PTSD

Led by VA Office of Research and Development · Updated on 2025-07-14

150

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Computational Assessment of GABA Receptor Modulation in PTSD

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Veteran
  • Age 18 to 65 years, inclusive
  • Willing to abstain from alcohol 24 hours before and after testing sessions
  • Able and willing to give written informed consent and comply with study requirements
  • For PTSD group: current diagnosis of PTSD based on CAPS-5 assessment
Not Eligible

You will not qualify if you...

  • Uncontrolled, significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine diseases, or psychiatric disorders that may affect participation or study results
  • Pregnancy or lactation
  • Lifetime history of chronic psychotic disorder or bipolar disorder type I
  • Current moderate or severe substance use disorder
  • Positive urine drug test for substances of abuse at screening and before drug administration (except THC, which requires retesting if positive)
  • Signs of drug or alcohol intoxication or withdrawal
  • Current use of benzodiazepines or opioids
  • Use of medications unsafe with lorazepam as judged by study physician
  • Past intolerance or allergy to lorazepam or other benzodiazepines
  • Active suicidal ideation or high suicide risk
  • History of traumatic brain injury with loss of consciousness over 30 minutes
  • Insufficient English language skills or impairments preventing informed consent or study participation
  • Any other condition or risk deemed unsuitable by the study physician
  • For healthy control group: any Axis I disorder
  • For fMRI participants: contraindications to MRI and not being right-handed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

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Research Team

V

Vitaliana R Vasquez, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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