RecruitingPhase 2NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

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.

Sponsor

NYU Langone Health

Enrollment

120 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury Post Traumatic Stress Disorder

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether cannabidiol (CBD) — a non-psychoactive compound from cannabis — can reduce symptoms of PTSD (post-traumatic stress disorder) either alone or in combination with a mild traumatic brain injury (TBI). **You may be eligible if...** - You meet the clinical criteria for PTSD (diagnosed using a standardized interview scale) - If participating in the PTSD + TBI group: you have had a mild traumatic brain injury (not an open head injury) - You have a stable living situation and can provide two contact references - You are willing to stop using all other cannabis or CBD products for the duration of the study - You are willing to use contraception if you could become pregnant **You may NOT be eligible if...** - You have had a moderate or severe traumatic brain injury - Your TBI occurred within the last 6 months - You have had a substance use disorder (other than mild alcohol use or nicotine) in the past 12 months - You have an open head injury history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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