Using cannabidiol to treat PTSD and traumatic brain injury symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, placebo-controlled study aimed at evaluating the efficacy of cannabidiol (CBD) in alleviating symptoms of post-traumatic stress disorder (PTSD) in individuals, some of whom also have mild traumatic brain injury (TBI). A total of 120 participants will be enrolled and divided into three groups: one receiving 400 mg of oral CBD daily, another receiving 800 mg daily, and a control group receiving a placebo. The treatment will last for 8 weeks, with the primary outcome measured by changes in PTSD symptoms using the Clinician-Administered PTSD Scale (CAPS-5). The study seeks to determine if CBD can effectively reduce PTSD symptoms compared to a placebo.

Why it matters

Who can join: the full rules

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.

Where it's running

• New York University School of Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Esther M Blessing, MD PhD — NYU
• Study coordinator: Esther Blessing, MD PhD
• Email: Esther.Blessing@nyulangone.org
• Phone: 646-754-4808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.