Initial Study Sesting Efficacy and Tolerability of PT150 for PTSD in Veterans

Open to people ages 18-65

• Provide signed and dated informed consent form
• Be a military service member or Veteran
• Male or female, 18-65 years of age
• Meet DSM-5 criteria for PTSD ≥ 3 months duration as determined by CAPS-5
• Normal vitals and a baseline EKG with clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias
• Self-reported medical history and brief physical examination with no clinically significant contraindications for study participation
• Blood laboratory test results for routine hematology, chemistries, liver and kidney function tests within acceptable limits
• Willing to comply with all study procedures including taking oral medication, the study schedule and be available for the duration of the study Biological females, if able to conceive, must agree to use 2 forms of non-hormonal, medically acceptable contraception.

• Severe alcohol or substance use disorders by DSM-5 criteria in past 3 months or positive urine test for substances other than cannabis
• History or diagnosis of neurodegenerative disorders, psychotic disorders or bipolar disorder. Current treatment with antipsychotic medication for mental health
• History of suicide attempts and/or current suicidal ideation with plan or intent
• Currently using psychotropic medication (except SSRI/SNRI) or other drugs or agents which might interact with study drug. Currently taking SSRI/SNRI antidepressants for less than 30 days. Benzodiazepines or sleep agents (e.g. eszopiclone; zolpidem) are excluded; exception: trazodone 25-50 mg qhs prn for sleep or prazosin for nightmares
• Be pregnant or nursing
• HRT dose not stable for a minimum of 3 months
• Evidence of a serious, chronic medical condition that would increase the risk of an adverse outcome or history of any serious metabolic or other disease known to affect the CNS
• Have evidence of untreated or unstable medical illness including cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+/AIDS infection
• Serious cognitive impairment likely to interfere with ability to meaningfully participate
• Past brain injury/head trauma with minor loss of consciousness and current symptoms or significant loss of consciousness
• Current signs of violence or aggression
• A history of adrenal insufficiency or a plasma cortisol level ≤ 5 mcg/dl at screening
• Receiving non-pharmacotherapy treatments or procedures for where precautions exist for taking with PT150 and/or those that might interfere with the study
• Contraindication(s) to take PT150 such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity to study drug or similar compounds
• Participation in a pharmaceutical trial or use of investigational drugs within 1 month of screening
• Hearing loss that would interfere with the extinction recall measures
• Any other illness, condition, or use of medications which in the opinion of the PI and/or study investigator would preclude safe and/or successful completion of the study