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Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Primary Purpose

Post Traumatic Stress Disorder, Traumatic Brain Injury

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol Group 1

Cannabidiol Group 2

Placebo Group

Arm Description

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.

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.

40 participants will be given a placebo for a total of 8 weeks treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.
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%.
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)

Full Information

First Posted
July 21, 2020
Last Updated
June 27, 2023
Sponsor
NYU Langone Health
Collaborators
Brockman Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04550377
Brief Title
Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Brockman Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol Group 1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cannabidiol Group 2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
40 participants will be given a placebo for a total of 8 weeks treatment.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
NANTHEIA™, A1002N5S
Intervention Description
The drug product to be used in this study is an oral formulation of CBD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
non-active medication
Primary Outcome Measure Information:
Title
Change in PTSD symptoms
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score.
Description
The PCL-5 is a 20-item self-report measure that assesses DSM-5 symptoms of PTSD. Higher scores indicate greater symptom severity.
Time Frame
Weekly over Weeks 1 to 8.
Title
Safety and tolerability of cannabidiol
Description
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).
Time Frame
All visits
Title
Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.
Description
The Criterion B (reexperiencing) severity score is the sum of the individual severity scores for CAPS-5 items 1-5.
Time Frame
Baseline, Week 8.
Title
Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.
Description
The Criterion C (Avoidance) severity score is the sum of the individual severity scores for CAPS-5 items 6 and 7.
Time Frame
Baseline, Week 8.
Title
Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.
Description
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.
Time Frame
Baseline, Week 8.
Title
Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal.
Description
The Criterion E (Hyperarousal) severity score is the sum of the individual severity scores for CAPS-5 items 15-20.
Time Frame
Baseline, Week 8.
Title
Frequency of substantial reduction in PTSD symptoms
Description
Number of subjects per arm with a reduction in Baseline - Week 8 CAPS-5 total score equal to or greater than 30%.
Time Frame
Baseline, Week 8
Title
Change in plasma CBD levels
Description
Peak and trough levels (Cmax) of plasma CBD will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS)
Time Frame
Day 1 (post first dose), Week 2, Week 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Blessing, MD PhD
Phone
646-754-4808
Email
Esther.Blessing@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther M Blessing, MD PhD
Organizational Affiliation
NYU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles R Marmar, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther M Blessing, MD PhD
Phone
646-754-4808
Email
esther.blessing@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Natalie Saba, BSc.
Email
Natalie.Saba@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

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