Post Traumatic Stress DisorderPhase 2NCT04550377
Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
A Phase 2 study testing Cannabidiol in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Traumatic Brain Injury
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Esther M Blessing, MD PhD, 646-754-4808, esther.blessing@nyulangone.org
Natalie Saba, BSc., Natalie.Saba@nyulangone.org
About this study
Official title: 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.
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called NANTHEIA™, A1002N5S
The drug product to be used in this study is an oral formulation of CBD
PlaceboDrug
non-active medication
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol Group 1 | Active comparator | 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. Receives: Drug: Cannabidiol |
| Cannabidiol Group 2 | Active comparator | 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. Receives: Drug: Cannabidiol |
| Placebo Group | Placebo comparator | 40 participants will be given a placebo for a total of 8 weeks treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms
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.
Measured: Baseline, Week 8
Secondary outcomes (8)
Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score.
The PCL-5 is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. Higher scores indicate greater symptom severity.
Measured: Weekly over Weeks 1 to 8.
Safety and tolerability of cannabidiol
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).
Measured: All visits
Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.
The Criterion B (reexperiencing) severity score is the sum of the individual severity scores for CAPS-5 items 1-5.
Measured: Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.
The Criterion C (Avoidance) severity score is the sum of the individual severity scores for CAPS-5 items 6 and 7.
Measured: Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.
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.
Measured: Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal.
The Criterion E (Hyperarousal) severity score is the sum of the individual severity scores for CAPS-5 items 15-20.
Measured: Baseline, Week 8.
Frequency of substantial reduction in PTSD symptoms
Number of subjects per arm with a reduction in Baseline - Week 8 CAPS-5 total score equal to or greater than 30%.
Measured: Baseline, Week 8
Change in plasma CBD levels
Peak and trough levels (Cmax) of plasma CBD will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS)
Measured: Day 1 (post first dose), Week 2, Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start26 May 2021
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Brockman Foundation
- Responsible party
- Sponsor
- Investigators
- Esther M Blessing, MD PhD, Principal investigator, NYUCharles R Marmar, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550377
- Sponsor's protocol ID
- 19-00962
- Status last verified
- Feb 2026
- First submitted
- 21 Jul 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04550377
- Acronym / sponsor ID
- 19-00962
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Brockman Foundation
- Study start
- 26 May 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol Group 1 | Active comparator | Drug: Cannabidiol40 participants will be titrated to a maximum dose of oral cannabidiol 800 mg daily over 2 weeks for a total of 8 weeks treatment. |
| Cannabidiol Group 2 | Active comparator | Drug: Cannabidiol40 participants will be titrated to a maximum dose of oral cannabidiol 400 mg daily over 2 weeks for a total of 8 weeks treatment. |
| Placebo Group | Placebo comparator | Drug: Placebo40 participants will be given a placebo for a total of 8 weeks treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: NANTHEIA™, A1002N5SThe drug product to be used in this study is an oral formulation of CBD | Drug | Cannabidiol Group 1, Cannabidiol Group 2 |
| Placebonon-active medication | Drug | Placebo Group |
Primary outcome
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.
8 secondary outcomes
Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score.
Time frame: Weekly over Weeks 1 to 8.
Safety and tolerability of cannabidiol
Time frame: All visits
Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.
Time frame: Baseline, Week 8.
Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.
Time frame: 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.
Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal.
Time frame: Baseline, Week 8.
Frequency of substantial reduction in PTSD symptoms
Time frame: Baseline, Week 8
Change in plasma CBD levels
Time frame: Day 1 (post first dose), Week 2, Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esther M Blessing, MD PhD principal investigator
NYU
Charles R Marmar, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Post Traumatic Stress Disorder and Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esther Blessing, MD PhD (646-754-4808, Esther.Blessing@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.