Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Post Traumatic Stress Disorder, Traumatic Brain Injury

In brief

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.

Key facts

Study ID: NCT04550377
Run by: NYU Langone Health
People needed: 120
Starts: 2021-05-26
Expected to finish: 2026-06-01
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

New York University School of Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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