Phase 4 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 man or woman between 18 and 75 years old with a history of serving in the U.S. military, can read and understand English, and are able to sign a consent form
• You have experienced a traumatic event that meets the official definition used to diagnose PTSD
• You have had PTSD symptoms for more than 3 months, confirmed by a structured assessment, and meet at least a partial PTSD diagnosis
• You have significant sleep problems, shown by a score above 14 on a standard insomnia questionnaire
• If you are currently taking certain antidepressants (such as sertraline, fluoxetine, paroxetine, citalopram, escitalopram, fluvoxamine, venlafaxine, duloxetine, desvenlafaxine, or levomilnacipran), your dose has been stable for at least 4 weeks before joining
• If you are currently in talk therapy, your treatment has been consistent for at least 6 weeks
• If you are a woman who could become pregnant, you are not currently pregnant, not breastfeeding, not planning to become pregnant during the study, and are using an approved form of birth control (such as the pill, an implant, an injection, a patch, an IUD, or a double-barrier method)
• Your sleep apnea screening score is below 30 (if you score between 5 and 30, a referral for further evaluation will be provided)

Who may not be able to join:

• You have been diagnosed with a moderate or severe alcohol or drug use disorder in the last 3 months (mild alcohol or marijuana use may be considered on a case-by-case basis — confirm with trial site)
• You have had a manic episode or psychosis within the last 5 years
• You have experienced a new traumatic event within the last 3 months
• You have had significant thoughts of harming yourself or others, or any suicidal behaviour, in the past 3 months, or your level of risk requires extra support or hospitalisation
• You have severe untreated sleep apnea (score above 30) and are not consistently using an effective treatment such as a CPAP machine or oral device
• You have a neurological condition or a body-wide illness that affects how your brain works (confirm with trial site)
• You have a serious or unstable physical health condition, such as unstable chest pain, a heart attack within the past 6 months, heart failure, persistent low blood pressure, irregular heartbeat, chronic kidney or liver failure, pancreatitis, or severe lung disease
• You have a history of severe traumatic brain injury
• You show signs of mild memory or thinking problems based on a standard cognitive test
• You are pregnant, breastfeeding, or unwilling to use effective birth control during the study (for women)
• You have narcolepsy (a condition causing sudden episodes of sleep)
• You have previously had a bad reaction to a sleeping medication
• You are currently taking benzodiazepines (a type of sedative), the heart medication digoxin, or certain medications that strongly affect how the body processes drugs (called strong CYP3A inhibitors — confirm with trial site)
• You regularly use substances that slow the brain and nervous system, such as opioids or alcohol, alongside the study medication
• You are taking certain antifungal, antibiotic, or antiviral medications, or drink grapefruit juice regularly, that could interfere with the study drug (confirm with trial site for a full list)

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