Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Led by NYU Langone Health · Updated on 2026-02-17

120

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

B

Brockman Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  • TBI present (for PTSD+TBI subjects only) as per American Congress of Rehabilitation Medicine (ACRM) definition
  • Mild TBI (for PTSD+TBI subjects only) as per Ohio State University Identification Screener
  • Able to provide at least 2 locators
  • Able to provide informed consent
  • Confirmation that the participant is reliably domiciled
  • Agreement to abstain from all other cannabinoid use for the duration of the study
  • Willingness to use contraception if of childbearing potential.
Not Eligible

You will not qualify if you...

  • History of open head injury
  • TBI within the last 6 months
  • Moderate or Severe TBI
  • Substance use disorder (SUD) in the last 12 months other than mild alcohol use disorder (AUD) or nicotine use
  • Use of any cannabinoid containing product within the last 1 month
  • Positive urine drug screen (for cannabinoids, amphetamine, cocaine, opioids)
  • Currently prescribed medications with possible CBD-drug interactions
  • Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder
  • Exposure to trauma in the last 30 days, including police duty or military service
  • Psychotherapy for PTSD or other psychiatric conditions initiated within 2 months of screening
  • Not stable for at least 2 months on psychiatric medication, anticonvulsants, antihypertensive medication, sympathomimetic medication, estrogen replacement therapy, medications associated with neurogenesis, or steroid medication
  • Active suicide attempt within the past year
  • Current significant suicidality or history of serious suicide attempts requiring hospitalization
  • Current significant homicidality
  • Neurologic disorder or systemic illness affecting central nervous system function (apart from TBI)
  • Major medical illness such as cancer or infectious disease
  • Clinical diagnosis of anemia, advised by physician to avoid blood draws
  • Significant laboratory abnormalities or impaired hepatic function
  • Significant allergic reactions to cannabinoids or sesame oil
  • Pregnancy or lactation
  • Contraindication to MRI
  • Males and females planning to conceive a child during or two weeks following the study
  • Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
  • High risk of adverse emotional or behavioral reaction such as serious personality disorder, antisocial behavior, serious current stressors, or lack of meaningful social support
  • Inpatient psychiatric treatment in past 12 months, except detox and extended emergency department stays

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

New York University School of Medicine

New York, New York, United States, 10016

Actively Recruiting

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Research Team

E

Esther Blessing, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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