RECRUITING

Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

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Conditions

Post Traumatic Stress DisorderTraumatic Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2021-05-26
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04550377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets clinical criteria for Posttraumatic Stress Disorder (PTSD) as per Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  2. * TBI present (for PTSD+TBI subjects only) as per American Congress of Rehabilitation Medicine (ACRM) definition
  3. * Mild TBI (for PTSD+TBI subjects only) as per Ohio State University Identification Screener
  4. * Able to provide at least 2 locators
  5. * Able to provide informed consent
  6. * Confirmation that the participant is reliably domiciled
  7. * Agreement to abstain from all other cannabinoid use for the duration of the study
  8. * Willingness to use contraception if of childbearing potential.
  1. * History of open head injury
  2. * TBI within the last 6 months
  3. * Moderate or Severe TBI
  4. * SUD in the last 12 months other than mild AUD or nicotine use
  5. * Use of any cannabinoid containing product within the last 1 month
  6. * Positive urine drug screen (Positive for cannabinoids, amphetamine, cocaine, opioids)
  7. * Currently prescribed medications with possible CBD-drug interactions
  8. * Lifetime history of any psychiatric disorder with psychotic features, bipolar disorder
  9. * Exposure to trauma in the last 30 days, including police duty or military service
  10. * Psychotherapy for PTSD or other psychiatric conditions initiated within 2 months of screening
  11. * 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
  12. * Active suicide attempt within the past year
  13. * 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.
  14. * Neurologic disorder or systemic illness affecting CNS function (apart from TBI)
  15. * Major medical illness (i.e. cancer or infectious disease.)
  16. * Clinical diagnosis of anemia, advised by physician to avoid blood draws
  17. * Significant laboratory abnormalities, significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel
  18. * Significant allergic reactions to the drug including cannabinoids or sesame oil
  19. * Pregnancy or lactation
  20. * Contraindication to MRI
  21. * Males and females who plan to conceive a child during or two weeks following the study
  22. * Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
  23. * 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).
  24. * Inpatient psychiatric treatment in past 12 months, with the exception of detox and extended ED stays.

Contacts and Locations

Study Contact

Esther Blessing, MD PhD
CONTACT
646-754-4808
Esther.Blessing@nyulangone.org

Principal Investigator

Esther M Blessing, MD PhD
PRINCIPAL_INVESTIGATOR
NYU
Charles R Marmar, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

New York University School of Medicine
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Esther M Blessing, MD PhD, PRINCIPAL_INVESTIGATOR, NYU
  • Charles R Marmar, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-26
Study Completion Date2026-06

Study Record Updates

Study Start Date2021-05-26
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder
  • Traumatic Brain Injury