Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат Cannabidiol
  The drug product to be used in this study is an oral formulation of CBD
• Препарат Placebo
  non-active medication

Первичные конечные точки

• Change in PTSD symptoms [Срок оценки: Baseline, Week 8]

Вторичные конечные точки (8)

• Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score. [Срок оценки: Weekly over Weeks 1 to 8.]
• Safety and tolerability of cannabidiol [Срок оценки: All visits]
• Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing. [Срок оценки: Baseline, Week 8.]
• Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance. [Срок оценки: Baseline, Week 8.]
• Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood. [Срок оценки: Baseline, Week 8.]
• Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal. [Срок оценки: Baseline, Week 8.]
• Frequency of substantial reduction in PTSD symptoms [Срок оценки: Baseline, Week 8]
• Change in plasma CBD levels [Срок оценки: Day 1 (post first dose), Week 2, Week 8.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New York University School of Medicine — New York

Идентификаторы

NCT: NCT04550377 · 19-00962

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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