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.
Overview
- Phase
- Phase 2
- Intervention
- Cannabidiol
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- NYU Langone Health
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in PTSD symptoms
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
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
Arms & Interventions
Cannabidiol Group 1
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.
Intervention: Cannabidiol
Cannabidiol Group 2
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.
Intervention: Cannabidiol
Placebo Group
40 participants will be given a placebo for a total of 8 weeks treatment.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in PTSD symptoms
Time Frame: Baseline, Week 8
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 Outcomes
- Change in CAPS-5 symptom cluster severity score for Criterion C, Avoidance.(Baseline, Week 8.)
- Change in plasma CBD levels(Day 1 (post first dose), Week 2, Week 8.)
- Change in PTSD symptoms measured with PTSD Checklist (PCL-5) total score.(Weekly over Weeks 1 to 8.)
- Safety and tolerability of cannabidiol(All visits)
- Change in CAPS-5 symptom cluster severity score for Criterion B, Reexperiencing.(Baseline, Week 8.)
- Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.(Baseline, Week 8.)
- Change in CAPS-5 symptom cluster severity score for Criterion E, Hyperarousal.(Baseline, Week 8.)
- Frequency of substantial reduction in PTSD symptoms(Baseline, Week 8)