Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Inclusion Criteria:

• Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as perClinician-Administered PTSD Scale for DSM-5 (CAPS-5)

• TBI present (for PTSD+TBI subjects only) as per American Congress of RehabilitationMedicine (ACRM) definition

• Mild TBI (for PTSD+TBI subjects only) as per Ohio State University IdentificationScreener

• Able to provide at least 2 locators

• Able to provide informed consent

• Confirmation that the participant is reliably domiciled

• Agreement to abstain from all other cannabinoid use for the duration of the study

• Willingness to use contraception if of childbearing potential.

Exclusion Criteria:

• History of open head injury

• TBI within the last 6 months

• Moderate or Severe TBI

• SUD in the last 12 months other than mild AUD or nicotine use

• Use of any cannabinoid containing product within the last 1 month

• Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine,opioids)

• Currently prescribed medications with possible CBD-drug interactions

• Lifetime history of any psychiatric disorder with psychotic features, bipolardisorder

• Exposure to trauma in the last 30 days, including police duty or military service

• Psychotherapy for PTSD or other psychiatric conditions initiated within 2 months ofscreening

• Not stable for at least 2 months on psychiatric medication, anticonvulsants,antihypertensive medication, sympathomimetic medication, estrogen replacementtherapy, medications associated with neurogenesis, or steroid medication

• Active suicide attempt within the past year

• Current significant suicidality (assessed using the C-SSRS), any significantsuicidal behavior in the past 12 months, or any history of serious suicide attemptsrequiring hospitalization, or current significant homicidality.

• Neurologic disorder or systemic illness affecting CNS function (apart from TBI)

• Major medical illness (i.e. cancer or infectious disease.)

• Clinical diagnosis of anemia, advised by physician to avoid blood draws

• Significant laboratory abnormalities, significantly impaired hepatic function,abnormalities in complete blood count or metabolic panel

• Significant allergic reactions to the drug including cannabinoids or sesame oil

• Pregnancy or lactation

• Contraindication to MRI

• Males and females who plan to conceive a child during or two weeks following thestudy

• Active legal problems likely to result in incarceration within 12 weeks of treatmentinitiation

• Has a high risk of adverse emotional or behavioral reaction (e.g., evidence ofserious personality disorder, antisocial behavior, serious current stressors, andlack of meaningful social support).

• Inpatient psychiatric treatment in past 12 months, with the exception of detox andextended ED stays.