Phase 2 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are a Veteran between 18 and 64 years old (male or female)
• You have chronic insomnia, meaning you have trouble falling asleep, staying asleep, or waking too early at least 3 nights per week for 3 or more months, and it affects your daytime functioning
• Your insomnia is rated as moderate or severe based on a standard questionnaire (score of 15 or higher on the Insomnia Severity Index)
• You have significant PTSD symptoms based on a standard checklist (score of 33 or higher on the PCL-5)
• You are willing and able to follow all parts of the study
• You agree not to start any new separate treatment programs for insomnia, PTSD, or other mental health conditions while in the study
• If you are a woman who could become pregnant and are sexually active, you agree to use an approved form of birth control starting 30 days before the study drug and until 30 days after your last dose (acceptable methods include hormonal contraceptives or a non-hormonal IUD)
• You are allowed to continue taking certain antidepressants or other approved psychiatric medications, as long as the dose has been stable for at least 1 month before joining

Who may not be able to join:

• You have been diagnosed with, or have a history of, schizophrenia, schizoaffective disorder, or bipolar disorder
• You are currently having thoughts of harming yourself or others that require immediate crisis help
• You currently have a moderate or severe problem with alcohol, cannabis, or other substance use
• You have a history of moderate or severe traumatic brain injury, stroke, epilepsy, multiple sclerosis, or similar neurological conditions
• You drink large amounts of caffeine late in the day (for example, caffeinated drinks after 6:00 PM, 3 or more times a week) in a way that the study team believes is worsening your insomnia
• You use tobacco close to bedtime in a way that the study team believes is affecting your sleep or would interfere with a sleep study
• You have been diagnosed with certain other sleep disorders (such as restless legs syndrome, narcolepsy, or sleepwalking disorder) that could make it hard to accurately assess your insomnia (confirm with trial site)
• You have been diagnosed with moderate to severe sleep apnea (a breathing problem during sleep), defined by a specific test score
• A screening questionnaire suggests you are at high risk for moderate to severe sleep apnea
• A sleep study done during screening shows signs of significant sleep apnea or other sleep problems
• Your heart's electrical activity (measured by an ECG) shows an abnormally long interval (QTc over 470 ms for men or 480 ms for women)
• You have recently been in therapy specifically for insomnia or PTSD (such as CBT-I, prolonged exposure, or cognitive processing therapy) within 1 week before joining, in a way that may affect study results
• You have a significant ongoing health condition affecting your heart, lungs, stomach, kidneys, liver, or nervous system that could affect your safety or the study results
• You are currently pregnant or breastfeeding
• You are a woman who could become pregnant and are not using an approved form of birth control
• You have a heart condition that puts you at risk for a dangerous irregular heartbeat (such as a condition called torsades de pointes or a naturally prolonged QT interval)
• You are currently taking sleeping aids or sedating medications at bedtime (such as melatonin, zolpidem, benzodiazepines, trazodone, antihistamines, opioids, and others) — these must be stopped at least 1 week before joining
• You are taking certain antipsychotic or antidepressant medications (such as quetiapine, olanzapine, mirtazapine, or trazodone) — these must be stopped at least 1 week before joining
• You are taking certain strong medications that could significantly raise or lower the level of the study drug in your body (confirm with trial site for specific medications)
• You are taking certain medications known to affect heart rhythm, including some heart medications, antipsychotics, and antibiotics (confirm with trial site for specific medications)

Important: Always verify eligibility with the trial site directly before applying.