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RECRUITING
NCT04550377
PHASE2

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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

DRUG

Cannabidiol

The drug product to be used in this study is an oral formulation of CBD

DRUG

Placebo

non-active medication

Locations (1)

New York University School of Medicine

New York, New York, United States