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Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
Sponsor: NYU Langone Health
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2021-05-26
Completion Date
2026-06
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Cannabidiol
The drug product to be used in this study is an oral formulation of CBD
Placebo
non-active medication
Locations (1)
New York University School of Medicine
New York, New York, United States