Cannabidiol as a Treatment for PTSD and PTSD Comorbid With TBI

NCT ID: NCT04550377

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

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

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

non-active medication

Interventions

Cannabidiol

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

Intervention Type: DRUG

Placebo

non-active medication

Intervention Type: DRUG

Other Intervention Names

NANTHEIA™; A1002N5S

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brockman Foundation

UNKNOWN

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther M Blessing, MD PhD

Role: PRINCIPAL_INVESTIGATOR

NYU

Charles R Marmar, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Esther Blessing, MD PhD

Role: CONTACT

Esther.Blessing@nyulangone.org

646-754-4808

Facility Contacts

Esther M Blessing, MD PhD

Role: primary

esther.blessing@nyulangone.org

646-754-4808

Natalie Saba, BSc.

Role: backup

Natalie.Saba@nyulangone.org

Other Identifiers

19-00962

Identifier Type: -

Identifier Source: org_study_id