Cannabidiol for Treating PTSD symptoms and Neurocognitive Impairment in PTSD and PTSD Comorbid with TBI: A Placebo-controlled RCT with Neural-circuit centered Precision Medicine Prediction of Response.

Brief description of study

This will be a randomized placebo controlled parallel dose finding study. The purpose of this project is to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD) and neurocognitive impairment. Subjects, 120 in total, will be males and females with PTSD with, or without comorbid mild–moderate traumatic brain injury (TBI) (60 patients each group). We expect around half of all subjesct to be veterans. There will be three study arms: 1) 40 subjects assigned to oral CBD 400 mg daily; 2) 40 subjects assigned to CBD 800 mg daily, and 3) 40 subjects assigned to Placebo daily. Treatment duration will be 8 weeks. Randomization will be stratified on two variables: m–mTBI and veteran status. In order to generate a biomarker-informed precision medicine estimate of patient characteristics that predict treatment response, neuroimaging and blood-based biomarkers will be collected at baseline and following 8 weeks of treatment.


Clinical Study Identifier: s19-00962
ClinicalTrials.gov Identifier: NCT04550377
Principal Investigator: Esther Blessing.
Other Investigators: Carole Siegel, Charles R. Marmar, Eugene M Laska.


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