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Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

NCT04550377 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cannabidiol

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

DRUG

Placebo

non-active medication

Sponsors & Collaborators

Principal Investigators

  • Esther M Blessing, MD PhD · NYU

  • Charles R Marmar, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2026-03-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04550377 on ClinicalTrials.gov