Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

February 12, 2026 updated by: NYU Langone Health

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cannabidiol Group 1
40 participants will be titrated to a maximum dose of oral cannabidiol 800 mg daily over 2 weeks for a total of 8 weeks treatment.
Drug: Cannabidiol
The drug product to be used in this study is an oral formulation of CBD
Other Names:
  • NANTHEIA™
  • A1002N5S
Active Comparator: Cannabidiol Group 2
40 participants will be titrated to a maximum dose of oral cannabidiol 400 mg daily over 2 weeks for a total of 8 weeks treatment.
Drug: Cannabidiol
The drug product to be used in this study is an oral formulation of CBD
Other Names:
  • NANTHEIA™
  • A1002N5S
Placebo Comparator: Placebo Group
40 participants will be given a placebo for a total of 8 weeks treatment.
Drug: Placebo
non-active medication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score.
Time Frame: Weekly over Weeks 1 to 8.
The PCL-5 is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. Higher scores indicate greater symptom severity.
Weekly over Weeks 1 to 8.
Safety and tolerability of cannabidiol
Time Frame: All visits
Frequency of adverse events collected at all visits following randomization for active arms. The specific tool that will be used to document adverse events is the SAFTEE (Parts A and B).
All visits
Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.
Time Frame: Baseline, Week 8.
The Criterion B (reexperiencing) severity score is the sum of the individual severity scores for CAPS-5 items 1-5.
Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.
Time Frame: Baseline, Week 8.
The Criterion C (Avoidance) severity score is the sum of the individual severity scores for CAPS-5 items 6 and 7.
Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.
Time Frame: Baseline, Week 8.
The Criterion D (Negative alterations in cognitions and mood) severity score is the sum of the individual severity scores for CAPS-5 items 8-14.
Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal.
Time Frame: Baseline, Week 8.
The Criterion E (Hyperarousal) severity score is the sum of the individual severity scores for CAPS-5 items 15-20.
Baseline, Week 8.
Frequency of substantial reduction in PTSD symptoms
Time Frame: Baseline, Week 8
Number of subjects per arm with a reduction in Baseline - Week 8 CAPS-5 total score equal to or greater than 30%.
Baseline, Week 8
Change in plasma CBD levels
Time Frame: Day 1 (post first dose), Week 2, Week 8.
Peak and trough levels (Cmax) of plasma CBD will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS)
Day 1 (post first dose), Week 2, Week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brockman Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Esther M Blessing, MD PhD, NYU
  • Principal Investigator: Charles R Marmar, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-00962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data. Upon reasonable request and to achieve aims in the approved proposal. quests should be directed to Esther.Blessing@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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