drugset / Trial / NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

NCT04550377

Phase 2 Recruiting 120 enrolled NYU Langone Health Brockman Foundation · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-05-26
Primary completion
2026-03
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cannabidiol Other / unclassified 400 mg Oral
Comparator Cannabidiol Other / unclassified 800 mg Oral