Cannabidiol for PTSD and TBI

Overview

This will be a randomized placebo controlled parallel dose finding study. The purpose of this project is to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic stress disorder (PTSD) and neurocognitive impairment. Subjects, 120 in total, will be males and females with PTSD with, or without comorbid mild-moderate traumatic brain injury (TBI) (60 patients each group). We expect around half of all subjesct to be veterans. There will be three study arms: 1) 40 subjects assigned to oral CBD 400 mg daily; 2) 40 subjects assigned to CBD 600 mg daily, and 3) 40 subjects assigned to Placebo daily. Treatment duration will be 8 weeks. In order to generate a biomarker-informed precision medicine estimate of patient characteristics that predict treatment response, neuroimaging and blood-based biomarkers will be collected at baseline and following 8 weeks of treatment.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2023

Detailed Description

The proposed study is an eight-week double-blind randomized placebo-controlled parallel dose-finding study of CBD's effects on PTSD symptoms and neurocognitive function in 120 patients with moderate to severe PTSD, 50% with comorbid mild-moderate TBI. There will be three arms, CBD 400 mg daily (n=40); CBD 600 mg daily (n=40) and placebo daily (n=40).

Interventions

  • Drug: Cannabidiol
    • The drug product to be used in this study (TN-C200M2 Oral Capsule) is a formulation of CBD dissolved in a liquid formulation at a concentration of 400 mg/g.
  • Drug: Placebo
    • The placebo capsules will only include sunflower lecithin and MCT Oil 60/40 Food Grade.

Arms, Groups and Cohorts

  • Experimental: Cannabidiol Group 1
    • 40 participants will be titrated to a maximum dose of Cannabidiol 400 mg daily over 2 weeks for a total of 8 weeks treatment.
  • Experimental: Cannabidiol Group 2
    • 40 participants will be titrated to a maximum dose of Cannabidiol 600 mg daily over 2 weeks for a total of 8 weeks treatment.
  • Placebo Comparator: Placebo Group
    • 40 participants will be given a placebo for a total of 8 weeks treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in PTSD symptoms in participants using Cannabidiol.
    • Time Frame: Week 8
    • Percent subjects with a Week 8 – Baseline reduction in PCL-5 equal to a greater than 30%. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.

Secondary Measures

  • Reduction in Anxiety symptoms in participants using Cannabidiol.
    • Time Frame: Week 8
    • Measured anxiety symptoms with self-reported GAD-7 questionnaire. General Anxiety Disorder 7 item scale (GAD-7) total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety,.
  • Reduction in Depression symptoms in participants using Cannabidiol.
    • Time Frame: Week 8
    • Measured symptoms of depression with PHQ-9. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as “0″ (not at all) to “3″ (nearly every day).

Participating in This Clinical Trial

Inclusion Criteria

  • Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  • CAPS-5 score equal or greater than 25 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 or Moderate TBI (for PTSD+TBI subjects only) as per Ohio State University Identification Screener

Exclusion Criteria

  • History of open head injury
  • TBI within the last 6 months
  • SUD in the last 12 months other than mild AUD or nicotine use
  • Used any cannabinoid containing product on more than one occasion within 30 days of eligibility screening or once within 14 days of eligibility screening
  • 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, or obsessive-compulsive disorder or current major depressive disorder
  • Exposure to trauma in the last 30 days, including police duty or military service
  • Change in trauma-related psychotherapy for PTSD within the last 6 months
  • 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 suicidal intention
  • 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 or EKG abnormalities, significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel, EKG abnormalities.
  • Significant Allergic reaction to cannabinoids
  • Pregnancy
  • Contraindication to MRI Medical History
  • Males and females who plan to conceive a child during or two weeks following the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • Brockman Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Esther Blessing, MD, Principal Investigator, NYU Langone Health
  • Overall Contact(s)
    • Esther Blessing, MD, 646-754-4808, Esther.Blessing@nyulangone.org

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