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:

• People who have served in the US military
• People who can read and understand English
• People who are able to give written consent to participate
• People with PTSD symptoms severe enough to score 23 or higher on a specific PTSD assessment called the CAPS-5, given at the screening visit
• Men and pre-menopausal women who agree to use two forms of reliable contraception during the trial, one of which must be a barrier method (such as a condom)
• People already taking an SSRI or SNRI antidepressant for PTSD, provided the dose has been stable for at least 8 weeks before joining
• People already taking trazodone for sleep, provided the dose has been stable
• People already taking opioid pain medication, provided the dose has been stable
• People currently in talk therapy or psychotherapy, provided that treatment has been stable for at least 6 weeks

Who may not be able to join:

• People who have had a problem with alcohol use serious enough to be diagnosed as Alcohol Use Disorder in the past 3 months
• People who have had a problem with marijuana or other drug use serious enough to be diagnosed as Substance Use Disorder in the past 3 months
• People who have ever been diagnosed with Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder (OCD), or Major Depressive Disorder with psychotic features
• People who have been through a deeply traumatic event in the past 3 months
• People currently taking certain antidepressants, such as doxepin or tricyclic antidepressants
• People currently taking certain mood-stabilising medications, such as lithium
• People currently taking antipsychotic medications
• People considered to be at high risk of suicide or violent behaviour
• People who have sleep apnea and are not currently receiving any treatment for it (such as a CPAP machine)
• People currently taking corticosteroid medications, whether taken by mouth or inhaled
• People with a history of neurological disease (conditions affecting the brain or nervous system)
• People with angina (chest pain from the heart), congestive heart failure, or low blood pressure
• People who have had a heart attack in the past 6 months
• People with a heart block or irregular heartbeat
• People with kidney failure, liver failure, or pancreatitis
• People with severe chronic obstructive pulmonary disease (COPD), a serious lung condition
• People with a history of liver disease where certain liver blood test results (AST or ALT) are more than twice the normal range
• People with a history of kidney disease where a kidney function blood test (eGFR) shows a result below 60 ml/min
• People with additional risk factors for a serious heart rhythm problem called Torsades de pointes — for example, heart failure, low potassium levels, or a family history of a heart condition called Long QT Syndrome
• People taking certain medications known to affect heart rhythm
• People taking certain medications that could interfere with how the study drug works
• People with high blood pressure that is not controlled by medication
• People with diabetes that is not well managed
• People with a history of certain types of head injuries (confirm with trial site)
• People with mild cognitive impairment (early-stage problems with memory or thinking)

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