NCT04550377 · NYU Langone Health
Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
What this study is about
This will be a randomly assigned placebo controlled study to test the effectiveness 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).
View original scientific description
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.
Interventions
DRUG
Cannabidiol
The drug product to be used in this study is an oral formulation of CBD
DRUG
Placebo
non-active medication
Primary outcome measures
Change in PTSD symptoms
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- New York, New York
Collaborators
Brockman Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations