Cannabidiol for PTSD

Overseen by Charles Marmar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: NYU Langone Health

Must not be taking: Psychiatric medications

Disqualifiers: Psychotic disorders, Bipolar, Recent trauma, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants are stable on certain medications for at least 2 months before joining. If you are on medications that might interact with CBD, you may need to stop or adjust them. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Cannabidiol (CBD) for treating PTSD?

Research suggests that CBD may help reduce anxiety and improve symptoms in PTSD by acting on the endocannabinoid system, which is involved in stress and emotional regulation. Studies in animals and some early human research indicate that CBD could be a promising treatment for PTSD, but more research is needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

Is cannabidiol (CBD) generally safe for human use?

CBD is generally considered safe, but it can cause side effects like sleep disturbances, liver issues, and interactions with other medications. Serious adverse reactions have been reported, especially when used with certain drugs, so monitoring and caution are advised. ^{1 2 6 7 8}

How is the drug Cannabidiol (CBD) unique in treating PTSD?

Cannabidiol (CBD) is unique in treating PTSD because it targets the endocannabinoid system, which is involved in regulating fear and defensive behaviors, and it is a non-psychotomimetic compound, meaning it doesn't cause the 'high' associated with cannabis. Unlike traditional PTSD treatments, CBD is being explored for its potential to reduce anxiety and improve sleep quality, which are common issues in PTSD patients. ^{1 2 5 9 10}

Research Team

Esther M Blessing, MD PhD

Principal Investigator

NYU

Charles Marmar, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for men and women with PTSD, some of whom also have mild TBI. Participants must not use other cannabinoids during the study, be able to consent, avoid conceiving children, and meet specific criteria for PTSD or TBI diagnosis. Those with recent severe mental health issues, certain medical conditions or treatments that could interact with CBD are excluded.

Inclusion Criteria

You have a mild traumatic brain injury, as determined by the Ohio State University Identification Screener, and you also have post-traumatic stress disorder.

Able to provide informed consent

Confirmation that the participant is reliably domiciled

Exclusion Criteria

You tried to harm yourself on purpose in the last year.

You have major problems with your liver, blood, or metabolism.

You had a traumatic brain injury in the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral cannabidiol or placebo daily for 8 weeks to assess changes in PTSD symptoms

8 weeks

Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol (Cannabinoid)

Trial Overview The study tests if cannabidiol (CBD) can help treat PTSD symptoms over an 8-week period. It has three groups: one taking 400 mg of CBD daily, another taking 800 mg daily, and a third receiving a placebo. The main goal is to see how much their PTSD symptoms improve using a specialized scale.

Participant Groups

Group I: Cannabidiol Group 1 Active Control 1 Intervention

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 II: Cannabidiol Group 2 Active Control 1 Intervention

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 III: Placebo Group Placebo Group 1 Intervention

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

Cannabidiol is already approved in Canada for the following indications:

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Brockman Foundation

Collaborator

Trials

1

Recruited

120+

Findings from Research

In a study of 11 adults with PTSD, 91% experienced a reduction in symptoms after 8 weeks of oral CBD treatment, with an average decrease in PTSD Checklist scores of 28%.

CBD was well tolerated by patients, with no discontinuations due to side effects, suggesting it may be a safe adjunct treatment for PTSD alongside standard psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. Elms, L., Shannon, S., Hughes, S., et al.[2020]

In a study of 33 PTSD patients, administering 300 mg of cannabidiol (CBD) before recalling a nonsexual traumatic event significantly reduced anxiety and cognitive impairment compared to a placebo.

However, CBD did not show a significant effect on anxiety or cognitive impairment in patients recalling sexual trauma, suggesting that the efficacy of CBD may depend on the nature of the traumatic event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anxiolytic effect of cannabidiol depends on the nature of the trauma when patients with post-traumatic stress disorder recall their trigger event. Bolsoni, LM., Crippa, JAS., Hallak, JEC., et al.[2022]

A systematic review of 10 studies suggests that medicinal cannabinoids like CBD, Δ9-THC, and nabilone may improve overall PTSD symptoms and specific issues such as sleep disorders and arousal disturbances, potentially enhancing quality of life.

While the results are promising for using cannabinoids as a treatment for PTSD, more research is necessary to fully understand the safety and long-term efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocannabinoid System as Therapeutic Target of PTSD: A Systematic Review. Steardo, L., Carbone, EA., Menculini, G., et al.[2021]

In a study with male Wistar rats, repeated administration of cannabidiol (CBD) effectively prevented long-lasting anxiety effects caused by predator exposure, suggesting its potential as a treatment for PTSD.

The study indicates that CBD's anti-anxiety effects may be linked to the facilitation of 5HT1A receptor neurotransmission, highlighting these receptors as a possible therapeutic target for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol blocks long-lasting behavioral consequences of predator threat stress: possible involvement of 5HT1A receptors. Campos, AC., Ferreira, FR., Guimarães, FS.[2013]

This study is the first placebo-controlled clinical trial examining the efficacy of cannabidiol (CBD) for treating PTSD, involving 150 participants over an 8-week period.

The trial compares the effects of two types of CBD (Isolate and Broad Spectrum) on PTSD symptoms, with outcomes measured using the PTSD Checklist for DSM-5, aiming to assess both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial. Telch, MJ., Fischer, CM., Zaizar, ED., et al.[2023]

Cannabidiol (CBD) has been associated with significant adverse events, particularly 'weight decreased', 'hypophagia', and 'insomnia', based on a disproportionality analysis of reports from the VigiBase® database involving various patients.

The interaction of CBD with the serotonin 5-HT1A receptor may explain the occurrence of insomnia, highlighting the need for careful monitoring of these side effects in patients using CBD for conditions like Lennox-Gastaut syndrome and Dravet syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Calapai, F., Mannucci, C., McQuain, L., et al.[2023]

Purified cannabidiol (CBD), specifically the product Epidiolex, is approved for treating seizures in certain syndromes, and there is growing evidence supporting its use for anxiety, psychosis, PTSD, and substance abuse, based on numerous clinical studies.

However, while there is some positive data for other conditions like sleep quality and Parkinson's disease, the overall evidence is limited, and large-scale phase 3 trials are needed to confirm CBD's efficacy across various indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic potential of purified cannabidiol. O'Sullivan, SE., Jensen, SS., Nikolajsen, GN., et al.[2023]

Cannabidiol (CBD) shows promise as a therapeutic option for treating COVID-19-related anxiety and post-traumatic stress symptoms, supported by small randomized controlled trials that demonstrate its anxiolytic effects in various populations.

Pre-clinical studies indicate that CBD interacts with specific receptors in the brain, such as cannabinoid receptors and serotonin receptors, which may help reduce anxiety and improve sleep quality, making it a potential candidate for further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could Cannabidiol Be a Treatment for Coronavirus Disease-19-Related Anxiety Disorders? O'Sullivan, SE., Stevenson, CW., Laviolette, SR.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. [2020]

2. Brazil pubmed.ncbi.nlm.nih.gov

The anxiolytic effect of cannabidiol depends on the nature of the trauma when patients with post-traumatic stress disorder recall their trigger event. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Endocannabinoid System as Therapeutic Target of PTSD: A Systematic Review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Cannabidiol blocks long-lasting behavioral consequences of predator threat stress: possible involvement of 5HT1A receptors. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The therapeutic potential of purified cannabidiol. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Could Cannabidiol Be a Treatment for Coronavirus Disease-19-Related Anxiety Disorders? [2022]