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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The drug product to be used in this study is an oral formulation of CBD
non-active medication
New York University School of Medicine
New York, New York, United States
RECRUITINGChange 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.
Time frame: Baseline, Week 8
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.
Time frame: Weekly over Weeks 1 to 8.
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).
Time frame: All visits
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.
Time frame: Baseline, Week 8.
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.
Time frame: Baseline, Week 8.
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.
Time frame: Baseline, Week 8.
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.
Time frame: Baseline, Week 8.
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%.
Time frame: Baseline, Week 8
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)
Time frame: Day 1 (post first dose), Week 2, Week 8.
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