Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Traumatic Brain Injury Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550377
• Other study ID #: 19-00962
• Status: Recruiting
• Phase: Phase 2
• Start date: May 26, 2021
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Esther Blessing, MD PhD
• Phone: 646-754-4808
• Email: Esther.Blessing[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

Drug:
• Cannabidiol
The drug product to be used in this study is an oral formulation of CBD
• Placebo
non-active medication

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Brockman Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 8
Secondary	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.	Weekly over Weeks 1 to 8.
Secondary	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).	All visits
Secondary	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.	Baseline, Week 8.
Secondary	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.	Baseline, Week 8.
Secondary	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.	Baseline, Week 8.
Secondary	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.	Baseline, Week 8.
Secondary	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%.	Baseline, Week 8
Secondary	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)	Day 1 (post first dose), Week 2, Week 8.