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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: March 2023
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).
- 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
- 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.
- 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
- 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
- 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
- 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
- Lead Sponsor
- NYU Langone Health
- Brockman Foundation
- Provider of Information About this Clinical Study
- 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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