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New treatment option for Stress Disorders, Post-Traumatic
Official title Computational Assessment of GABA Receptor Modulation in PTSD
ClinicalTrials.gov ID: NCT06852469
What this study is testing
What is Lorazepam 1 mg tablet?
Lorazepam 1 mg tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for stress disorders, post-traumatic.
Also referred to as Ativan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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 for PTSD...
You likely can't join if
- Exclusion Criteria:
- Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic...
- 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. people who screen...
See the full eligibility criteria
- 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 for PTSD Group: (a) Current diagnosis of PTSD based on CAPS-5.
- Exclusion Criteria:
- Has uncontrolled, clinically significant neurologic (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric...
- 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. people who screen positive for THC will be given an opportunity to be included in the event...
- Self-report or observable signs of drug or alcohol intoxication or withdrawal;
- 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...
- 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...
- Contraindication to magnetic resonance imaging.
- Not right-handed as assessed by Edinburgh Handedness Inventory.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.