Computational Assessment of GABA Receptor Modulation in PTSD

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

Computational Assessment of GABA Receptor Modulation in PTSD (NCT06852469) is a Phase 4 interventional studying Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Stress Disorders, Post-Traumatic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Who May Qualify: 1. Veteran; 2. 18-65 years of age, inclusive; 3. Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session; 4. Participants must be able to participate and willing to give written willing to sign a consent form and to comply with the study restrictions; Additional Inclusion Criteria for PTSD Group: (a) Current diagnosis of PTSD based on CAPS-5. Who Should NOT Join This Trial: Who Should NOT Join This Trial: 1. Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results; 2. Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation; 3. Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI; 4. Current moderate or severe substance use disorder as assessed by MINI; 5. Positive urine toxicology (drugs of abuse as determined by a positive urine test) at screening and before drug administration. Subjects who screen positive for THC will be given an opportunity to be included in the event of a negative urine test 2 weeks later. THC is not infrequently used for medicinal purposes and, in California, is legal for recreational use. Subjects who are positive for THC will therefore not be excluded, but will be retested to ensure that THC is unlikely to be influencing results; 6. Self-report or observable signs of drug or alcohol intoxication or withdrawal; 7. Current benzodiazepine or opioid use; other psychotropic medications are allowed as long as they are at a stable dose for at least 2 weeks and do not exhibit an unsafe interaction with the study medication; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Inclusion Criteria: 1. Veteran; 2. 18-65 years of age, inclusive; 3. Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session; 4. Participants must be able to participate and willing to give written informed consent and to comply with the study restrictions; Additional Inclusion Criteria for PTSD Group: (a) Current diagnosis of PTSD based on CAPS-5. Exclusion Criteria: Exclusion Criteria: 1. Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric disorder, or other abnormality, which may impact the ability of the subject to participate or potentially confound the study results; 2. Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation; 3. Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI; 4. Current moderate or severe substance use disorder as assessed by MINI; 5. Positive urine toxicology (drugs of abuse as determined by a positive urine test) at screening and before drug administration. Subjects who screen positive for THC will be given an opportunity to be included in the event of a negative urine test 2 weeks later. THC is not infrequently used for medicinal purposes and, in California, is legal for recreational use. Subjects who are positive for THC will therefore not be excluded, but will be retested to ensure that THC is unlikely to be influencing results; 6. Self-report or observable signs of drug or alcohol intoxication or withdrawal; 7. Current benzodiazepine or opioid use; other psychotropic medications are allowed as long as they are at a stable dose for at least 2 weeks and do not exhibit an unsafe interaction with the study medication; 8. Current or recent use of any medication deemed by the study physician (Dr. Howlett) to exhibit an unsafe interaction with lorazepam; 9. Past intolerance (including allergic) to lorazepam or another benzodiazepine; 10. Active suicidal ideation or otherwise considered at high suicidal risk by trained study staff using the C-SSRS; 11. History of a traumatic brain injury (TBI) resulting in loss of consciousness for more than 30 minutes; 12. Volunteers who do not have sufficient command of the English language, or who have any other impairment that would prevent them from reading and understanding the informed consent form(s) and completing the study procedures including clinical testing; 13. Any other reason why, per study physician, the subject should not participate in this study, including concomitant disease or condition that could interfere with, or for which the study drug might interfere with, the conduct of the study, or that would, in the opinion of the study physician, pose an unacceptable risk to the subject in this study. Additional Exclusion Criteria for HC Group: (a) Axis I disorder as assessed by MINI. Additional Exclusion Criteria for fMRI Participants: 1. Contraindication to magnetic resonance imaging. 2. Not right-handed as assessed by Edinburgh Handedness Inventory.

Treatments Being Tested

DRUG

Lorazepam 1 mg tablet

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

DRUG

Placebo tablet

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06852469), the sponsor (VA Office of Research and Development), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06852469 clinical trial studying?

Who can participate in NCT06852469?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06852469?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06852469. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06852469. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.