Computational Assessment of GABA Receptor Modulation in PTSD
Part of paid clinical trials in San Diego, California.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT06852469
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Stress Disorders, Post-Traumatic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Lorazepam 1 mg tablet — DRUGLorazepam is an oral medication which is FDA approved to treat anxiety.
- Placebo tablet — DRUGPlacebo will match the study drug in mode of administration, color, size, and taste.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Jun 30, 2029
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Lorazepam 1 mg, then placeboParticipants will first receive a single dose of lorazepam 1 mg on the first testing session. After a 1 week washout period, participants will then receive a single dose of placebo on the second testing session.
- Experimental: Placebo, then lorazepam 1 mgParticipants will first receive a single dose of placebo on the first testing session. After a 1 week washout period, participants will then receive a single dose of lorazepam 1 mg on the second testing session.
Primary Outcome Measure
Dynamic inhibition during sensorimotor control [ Time Frame: 1.5 hours after dosing ]
Central Contacts
- Vitaliana R Vasquez, BA(858) 642-1256
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | Jonathan R Howlett, MD (PRINCIPAL_INVESTIGATOR) |
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