Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

NCT04550377 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 19-00962
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline, Week 8

Secondary Outcomes (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 C, Avoidance.

  Baseline, Week 8.

• Change in CAPS-5 symptom cluster severity score for Criterion D, Negative alterations in cognitions and mood.

  Baseline, Week 8.

Study Arms (3)

Cannabidiol Group 1

ACTIVE COMPARATOR

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.

Drug: Cannabidiol

Cannabidiol Group 2

ACTIVE COMPARATOR

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.

Drug: Cannabidiol

Placebo Group

PLACEBO COMPARATOR

40 participants will be given a placebo for a total of 8 weeks treatment.

Drug: Placebo

Interventions

Cannabidiol DRUG

The drug product to be used in this study is an oral formulation of CBD

Also known as: NANTHEIA™, A1002N5S

Cannabidiol Group 1; Cannabidiol Group 2

Placebo DRUG

non-active medication

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• NYU Langone Health: lead
• Brockman Foundation: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Esther M Blessing, MD PhD

  NYU

  PRINCIPAL INVESTIGATOR

• Charles R Marmar, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Blessing, MD PhD

CONTACT

646-754-4808; Esther.Blessing@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: September 16, 2020
• Study Start: May 26, 2021
• Primary Completion: March 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request and to achieve aims in the approved proposal. quests should be directed to Esther.Blessing@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)