Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

Exclusion Criteria

• •1. Currently incarcerated, paroled, or on probation
• •2. Participant has retained an attorney in relation to the TBI
• •3. Pregnant at the time of study enrollment or unwilling to commit to the use of two forms of contraception throughout the duration of the study
• •4. Vision, hearing, or communication impairments that preclude valid completion of study assessments
• •5. History of autism spectrum disorders, intellectual disability, and/or serious neurological or central nervous system disease that would be expected to affect cognition (e.g., epilepsy, tumors, multiple sclerosis)
• •6. Evidence of poor effort (TOMMe \< 8) on neuropsychological testing at baseline/Week 0
• •7. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)
• •8. Meets criteria for major depressive episode as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022) and with a Beck Depression Inventory-2 score \> 24;
• •9. Current suicidal ideation, as indicated by Beck Depression Inventory-2 item #9 score \> 0, or C-SSRS endorsement of item #2, or verbal or written report of current suicidal ideation by the participant to any study team member
• •10. History of significant systemic illness or unstable medical condition
• •11. Alcohol use disorder score of 5 or greater, or substance use disorder, based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022), in the six months preceding study enrollment
• •12. Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline;
• •13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
• •14. Current diagnosis of a seizure disorder or epilepsy
• •15. Report using cannabis once daily or more than once daily over the last 12 months
• •16. Report current use of CBD for medical reasons or TBI symptoms
• •17. Liver function enzymes (AST, ALT) that are greater than 2x normal