Stress Disorders, Post-TraumaticPhase 4NCT06852469
Computational Assessment of GABA Receptor Modulation in PTSD
A Phase 4 study testing Lorazepam 1 mg tablet in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Lorazepam 1 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran;
- 18-65 years of age, inclusive;
- Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session;
- 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:
- Current diagnosis of PTSD based on CAPS-5.
Who cannot join
- 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;
- Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation;
- Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI;
- Current moderate or severe substance use disorder as assessed by MINI;
- 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;
- Self-report or observable signs of drug or alcohol intoxication or withdrawal;
Show all 18Show fewer
- 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;
- Current or recent use of any medication deemed by the study physician (Dr. Howlett) to exhibit an unsafe interaction with lorazepam;
- Past intolerance (including allergic) to lorazepam or another benzodiazepine;
- Active suicidal ideation or otherwise considered at high suicidal risk by trained study staff using the C-SSRS;
- History of a traumatic brain injury (TBI) resulting in loss of consciousness for more than 30 minutes;
- 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;
- 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:
- Axis I disorder as assessed by MINI.
- Additional Exclusion Criteria for fMRI Participants:
- Contraindication to magnetic resonance imaging.
- Not right-handed as assessed by Edinburgh Handedness Inventory.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Vitaliana R Vasquez, BA, (858) 642-1256, Vitaliana.Vasquez@va.gov
Jonathan R Howlett, MD
About this study
Official title: Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder
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.
Read the detailed description
Heterogeneity in Veterans with PTSD has been identified as a major obstacle in developing effective treatments for this population. Research suggests that a PTSD subgroup characterized by elevated arousal, relative to general negative affect, may benefit from novel medications that positively modulate inhibitory gamma aminobutyric acid (GABA) signaling. An objective, functional phenotypic marker for this subgroup could therefore enable targeted treatment and improve clinical outcomes. The investigators propose a computational goal-directed control paradigm as a novel clinical assessment based on the premise that a reduction in dynamic inhibition, regulated by GABA signaling, can serve as a specific, objective phenotypic target in a high arousal PTSD (HA-PTSD) subgroup. This study will leverage: 1) a single dose of a benzodiazepine as an acute GABA receptor modulator for phenotypic target validation rather than treatment purposes; 2) a novel computational control modeling strategy to precisely measure the effect of GABA receptor modulation on dynamic inhibition; 3) functional neuroimaging to assess specific neural mechanisms of GABAergic influence on dynamic inhibition.
The investigators have developed the rapid assessment of motor processing (RAMP) paradigm, a computational goal-directed control task which enables precise estimation of a dynamic inhibition parameter. Compared to other behavioral measures, dynamic inhibition exhibits excellent measurement reliability. Dynamic inhibition is negatively associated with subjective fear, and this relationship persists after controlling for general negative affect. Critically, dynamic inhibition is lower in an HA-PTSD subgroup (with high residual fear, controlling for negative affect) compared to both a low arousal PTSD (LA-PTSD) subgroup and healthy controls (HC). Dynamic inhibition is also associated with structure and function in arousal-related regions such as dorsal anterior cingulate cortex (dACC) and insula.
Benzodiazepines are robust positive GABA receptor modulators which acutely reduce anxious arousal but result in tolerance and side effects when used chronically. Several novel pharmacotherapies (either FDA-approved for other indications or currently in development) may chronically normalize deficient GABA signaling without the downsides of chronic benzodiazepines. Given heterogeneity in PTSD, precision phenotyping will be critical for assigning these treatments to Veterans most likely to benefit, i.e. to an HA-PTSD group with deficient GABA signaling. The investigators propose that RAMP dynamic inhibition can serve as a specific, objective phenotypic target for positive GABA modulation in HA-PTSD. While preliminary data from the investigators has established a specific relationship between dynamic inhibition and fear (relative to negative affect), a crucial step prior to clinical use is validation of the relationship between dynamic inhibition and GABA receptor modulation. The investigators propose to test this causal relationship using the benzodiazepine lorazepam as a pharmacologic probe (rather than a clinical treatment). The validated phenotypic target can then be used for subgroup assignment and mechanistic outcome-tracking in trials of novel GABAergic agents for HA-PTSD.
The investigators hypothesize that the HA-PTSD group will show greater enhancement in dynamic inhibition than other groups with lorazepam compared to placebo. To test this hypothesis, the investigators propose a randomized crossover study in which HA-PTSD, LA-PTSD, and HC Veterans receive a single dose of the lorazepam and placebo in separate experimental sessions in which they perform the RAMP paradigm. Research suggests that arousal-related neural regions may specifically mediate the benefits of GABAergic modulation in HA-PTSD, which could enable targeting of more specific GABAergic treatments. The investigators will therefore examine specific neural mechanisms of GABAergic modulation using fMRI combined with dynamic inhibition as a phenotypic marker.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Lorazepam 1 mg tablet, Placebo tablet
- Keywords
- Arousal, gamma-Aminobutyric Acid, Lorazepam, Neuroimaging, Stress Disorders, Post-Traumatic
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorazepam 1 mg tabletDrug
Also called Ativan
Lorazepam is an oral medication which is FDA approved to treat anxiety.
Placebo tabletDrug
Placebo will match the study drug in mode of administration, color, size, and taste.
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam 1 mg, then placebo | Experimental | 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. Receives: Drug: Lorazepam 1 mg tablet; Drug: Placebo tablet |
| Placebo, then lorazepam 1 mg | Experimental | 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. Receives: Drug: Lorazepam 1 mg tablet; Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic inhibition during sensorimotor control
A dynamic inhibition parameter will be computed for each participant and session using a proportional-derivative (PD) model of sensorimotor control performance on the rapid assessment of motor processing (RAMP) task.
Measured: 1.5 hours after dosing
Secondary outcomes (2)
Neural activity during sensorimotor control
Blood oxygen level dependent (BOLD) response in the dorsal anterior cingulate cortex (dACC), insula, and amygdala (defined according to the Harvard-Oxford anatomical atlas) and in the whole brain will be measured during sensorimotor control performance on the rapid assessment of motor processing (RAMP) task. Bonferroni corrections will be performed based on the number of regions-of-interest (ROIs).
Measured: 1.5 hours after dosing
Change from baseline in the the Positive and Negative Affect Schedule - Expanded Form (PANAS X) Fear score
The change from baseline in the PANAS X Fear score will be measured. The PANAS X Fear subscale consists of 6 items. Items are answered on a 5 point scale, 1 (very slightly or not at all) to 5 (extremely). PANAS X Fear scores range from 6-30, with higher scores representing higher levels of fear.
Measured: Baseline, 1.5 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jul 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each included participant will be administered a dose of lorazepam 1 mg and placebo in a crossover design, with the order of lorazepam and placebo determined in double-blind, randomized fashion (using a randomly permuted block design), with a one-week washout period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan R Howlett, MD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852469
- Sponsor's protocol ID
- MHBP-009-24S
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Request may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System the requests may be sent to the Associate Chief of Staff for Research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06852469
- Acronym / sponsor ID
- MHBP-009-24S
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Arousal, gamma-Aminobutyric Acid, Lorazepam, Neuroimaging, Stress Disorders, Post-Traumatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heterogeneity in Veterans with PTSD has been identified as a major obstacle in developing effective treatments for this population. Research suggests that a PTSD subgroup characterized by elevated arousal, relative to general negative affect, may benefit from novel medications that positively modulate inhibitory gamma aminobutyric acid (GABA) signaling. An objective, functional phenotypic marker for this subgroup could therefore enable targeted treatment and improve clinical outcomes. The investigators propose a computational goal-directed control paradigm as a novel clinical assessment based on the premise that a reduction in dynamic inhibition, regulated by GABA signaling, can serve as a specific, objective phenotypic target in a high arousal PTSD (HA-PTSD) subgroup. This study will leverage: 1) a single dose of a benzodiazepine as an acute GABA receptor modulator for phenotypic target validation rather than treatment purposes; 2) a novel computational control modeling strategy to precisely measure the effect of GABA receptor modulation on dynamic inhibition; 3) functional neuroimaging to assess specific neural mechanisms of GABAergic influence on dynamic inhibition.
The investigators have developed the rapid assessment of motor processing (RAMP) paradigm, a computational goal-directed control task which enables precise estimation of a dynamic inhibition parameter. Compared to other behavioral measures, dynamic inhibition exhibits excellent measurement reliability. Dynamic inhibition is negatively associated with subjective fear, and this relationship persists after controlling for general negative affect. Critically, dynamic inhibition is lower in an HA-PTSD subgroup (with high residual fear, controlling for negative affect) compared to both a low arousal PTSD (LA-PTSD) subgroup and healthy controls (HC). Dynamic inhibition is also associated with structure and function in arousal-related regions such as dorsal anterior cingulate cortex (dACC) and insula.
Benzodiazepines are robust positive GABA receptor modulators which acutely reduce anxious arousal but result in tolerance and side effects when used chronically. Several novel pharmacotherapies (either FDA-approved for other indications or currently in development) may chronically normalize deficient GABA signaling without the downsides of chronic benzodiazepines. Given heterogeneity in PTSD, precision phenotyping will be critical for assigning these treatments to Veterans most likely to benefit, i.e. to an HA-PTSD group with deficient GABA signaling. The investigators propose that RAMP dynamic inhibition can serve as a specific, objective phenotypic target for positive GABA modulation in HA-PTSD. While preliminary data from the investigators has established a specific relationship between dynamic inhibition and fear (relative to negative affect), a crucial step prior to clinical use is validation of the relationship between dynamic inhibition and GABA receptor modulation. The investigators propose to test this causal relationship using the benzodiazepine lorazepam as a pharmacologic probe (rather than a clinical treatment). The validated phenotypic target can then be used for subgroup assignment and mechanistic outcome-tracking in trials of novel GABAergic agents for HA-PTSD.
The investigators hypothesize that the HA-PTSD group will show greater enhancement in dynamic inhibition than other groups with lorazepam compared to placebo. To test this hypothesis, the investigators propose a randomized crossover study in which HA-PTSD, LA-PTSD, and HC Veterans receive a single dose of the lorazepam and placebo in separate experimental sessions in which they perform the RAMP paradigm. Research suggests that arousal-related neural regions may specifically mediate the benefits of GABAergic modulation in HA-PTSD, which could enable targeting of more specific GABAergic treatments. The investigators will therefore examine specific neural mechanisms of GABAergic modulation using fMRI combined with dynamic inhibition as a phenotypic marker.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each included participant will be administered a dose of lorazepam 1 mg and placebo in a crossover design, with the order of lorazepam and placebo determined in double-blind, randomized fashion (using a randomly permuted block design), with a one-week washout period
| Arm | Type | Receives |
|---|---|---|
| Lorazepam 1 mg, then placebo | Experimental | Drug: Lorazepam 1 mg tablet, Drug: Placebo tabletParticipants 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. |
| Placebo, then lorazepam 1 mg | Experimental | Drug: Lorazepam 1 mg tablet, Drug: Placebo tabletParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran;
- 18-65 years of age, inclusive;
- Participants must be willing to abstain from alcohol 24 hours prior to and 24 hours after the testing session;
- Participants must be able to participate and willing to give written informed consent and to comply with the study restrictions;
- Current diagnosis of PTSD based on CAPS-5.
Key exclusion criteria (18 listed)
- 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;
- Pregnancy (assessed by urine test at time of screening and prior to administration of study medication) or lactation;
- Lifetime history of a chronic psychotic disorder or bipolar disorder type I as assessed by MINI;
- Current moderate or severe substance use disorder as assessed by MINI;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorazepam 1 mg tabletAlso: AtivanLorazepam is an oral medication which is FDA approved to treat anxiety. | Drug | Lorazepam 1 mg, then placebo, Placebo, then lorazepam 1 mg |
| Placebo tabletPlacebo will match the study drug in mode of administration, color, size, and taste. | Drug | Lorazepam 1 mg, then placebo, Placebo, then lorazepam 1 mg |
Primary outcome
Dynamic inhibition during sensorimotor control
Time frame: 1.5 hours after dosing
A dynamic inhibition parameter will be computed for each participant and session using a proportional-derivative (PD) model of sensorimotor control performance on the rapid assessment of motor processing (RAMP) task.
2 secondary outcomes
Neural activity during sensorimotor control
Time frame: 1.5 hours after dosing
Change from baseline in the the Positive and Negative Affect Schedule - Expanded Form (PANAS X) Fear score
Time frame: Baseline, 1.5 hours after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Request may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System the requests may be sent to the Associate Chief of Staff for Research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan R Howlett, MD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorazepam 1 mg tablet in people with Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vitaliana R Vasquez, BA ((858) 642-1256, Vitaliana.Vasquez@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic inhibition during sensorimotor control (time frame: 1.5 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.