Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
Trial Parameters
Brief Summary
This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD). Subjects, 120 in total, will be males and females with PTSD, half of which will have comorbid mild traumatic brain injury (TBI). There will be three study arms, each with 40 subjects: 1) Oral CBD 400 mg daily; 2) Oral CBD 800 mg daily, and 3) Placebo daily. Treatment duration will be 8 weeks. The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score.
Eligibility Criteria
Inclusion Criteria: * Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) * TBI present (for PTSD+TBI subjects only) as per American Congress of Rehabilitation Medicine (ACRM) definition * Mild TBI (for PTSD+TBI subjects only) as per Ohio State University Identification Screener * 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 p