Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Cannabidiol for Treating PTSD Symptoms and Neurocognitive Impairment in PTSD and PTSD Comorbid With TBI: A Placebo-controlled RCT With Neural-circuit Centered Precision Medicine Prediction of Response.

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI (NCT04550377) is a Phase 2 interventional studying Post Traumatic Stress Disorder and Traumatic Brain Injury, sponsored by NYU Langone Health. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Post Traumatic Stress Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Post Traumatic Stress Disorder subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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. Who Should NOT Join This Trial: - 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.) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Cannabidiol

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

DRUG

Placebo

non-active medication

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

New York University School of Medicine

New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04550377), the sponsor (NYU Langone Health), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04550377 clinical trial studying?

Who can participate in NCT04550377?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04550377?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04550377. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04550377. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.