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Cannabidiol for PTSD and PTSD with Traumatic Brain Injury

This study is testing if cannabidiol (CBD), an oral medication, can help reduce symptoms of post-traumatic stress disorder (PTSD). It also includes people who have both PTSD and a mild traumatic brain injury (TBI). You would be randomly assigned to receive either 400 mg of CBD daily, 800 mg of CBD daily, or a placebo (a non-active medication). The study plans to enroll 120 adults, aged 18 to 70, who meet specific criteria for PTSD. Half of the participants will also have a mild TBI. The main goal is to see how much PTSD symptoms change after 8 weeks of treatment, as measured by a specific PTSD assessment.

Study design
This is a randomized, placebo-controlled study involving 120 participants. There are three groups: two receiving different doses of oral CBD, and one receiving a placebo.
What's involved
Treatment will last for 8 weeks. Your PTSD symptoms will be measured at the beginning of the study and again at Week 8.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 8, which is the end of the treatment duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Recruiting
PHASE2Ages 18–70InterventionalTreatment
NYU Langone Health
~120 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:CannabidiolPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in PTSD symptoms
Measured over Baseline, Week 8

Conditions

Post Traumatic Stress Disorder
Traumatic Brain Injury

Explore related trials

Post-Traumatic Stress DisorderTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Esther M Blessing, MD PhD · PRINCIPAL_INVESTIGATOR · NYU
  • Charles R Marmar, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Esther Blessing, MD PhD
[email protected]
646-754-4808
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

Exclusion

History of open head injury
TBI within the last 6 months
Moderate or Severe TBI
SUD in the last 12 months other than mild AUD or nicotine use
Use of any cannabinoid containing product within the last 1 month
Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine, opioids)
Currently prescribed medications with possible CBD-drug interactions
Lifetime history of any psychiatric disorder with psychotic features, 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 (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidality.
Neurologic disorder or systemic illness affecting CNS function (apart from TBI)
Major medical illness (i.e. cancer or infectious disease.)
Clinical diagnosis of anemia, advised by physician to avoid blood draws
Significant laboratory abnormalities, significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel
Significant allergic reactions to the drug including cannabinoids or sesame oil
Pregnancy or lactation
Contraindication to MRI
Males and females who plan 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
Has a high risk of adverse emotional or behavioral reaction (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, and lack of meaningful social support).
Inpatient psychiatric treatment in past 12 months, with the exception of detox and extended ED stays.

What this trial measures

  • Change in PTSD symptomsBaseline, Week 8

    Baseline - Week 8 change in Clinician-Administered PTSD Scale (CAPS-5) total score. The CAPS-5 is the gold standard clinician administered interview for diagnosing PTSD and assessing symptom severity. Total CAPS-5 scores range from 0-80. Higher scores indicate greater symptom severity.