Stress Disorders, Post-Traumatic study: Lorazepam
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?
This is an investigational oral medication being studied to help identify which Veterans with post-traumatic stress disorder (PTSD) might respond to specific treatments. It is designed to boost the activity of a brain chemical called GABA, which helps calm nervous system signals.
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
- This study is looking at a new way to find out which brain type you have. It aims to help doctors pick the right medicine for your specific PTSD symptoms.
- Who it's for
- You may be able to join if you are a Veteran with PTSD and high levels of anxiety.
- What's involved
- You would take a short pill called lorazepam. You would also have brain scans to see how your brain reacts to the medicine.
- Time commitment
- The study involves specific visits for brain scans and medication checks.
- 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
You likely can't join if
- 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.
- Self-report or observable signs of drug or alcohol intoxication or withdrawal;
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.
- 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.
- 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...
- Contraindication to magnetic resonance imaging.
- Not right-handed as assessed by Edinburgh Handedness Inventory.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at San Diego, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.