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 — DRUG
    Lorazepam is an oral medication which is FDA approved to treat anxiety.
  • Placebo tablet — DRUG
    Placebo 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 placebo
    Participants 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 mg
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Vitaliana R Vasquez, BA
858-642-1256
Jonathan R Howlett, MD (PRINCIPAL_INVESTIGATOR)

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