Cannabidiol for PTSD

Overseen By Mark Rosenfeld

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: Psychiatric medications

Disqualifiers: Psychotic disorders, Bipolar, Recent trauma, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cannabidiol (CBD) can reduce symptoms of post-traumatic stress disorder (PTSD). Participants will receive either 400 mg of CBD, 800 mg of CBD, or a placebo daily for 8 weeks to determine which is most effective. Individuals with PTSD, with or without a mild traumatic brain injury, who can refrain from using other cannabinoid products during the study, might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cannabidiol (CBD) is usually easy for people to handle. In other studies, people using CBD have reported only mild side effects, such as sleepiness or dry mouth.

Studies have found no major safety issues with CBD, even at higher doses. The FDA has already approved CBD for other uses, such as treating certain types of epilepsy, suggesting it is generally safe for people.

In this new trial for PTSD, researchers are testing two different daily doses of CBD: 400 mg and 800 mg. Previous research at similar doses did not show any serious side effects. However, as with any new treatment, researchers will closely monitor participants to ensure everyone's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabidiol (CBD) for PTSD because it offers a new approach compared to traditional treatments like SSRIs and therapy. Unlike these standard options, CBD is derived from cannabis and targets the endocannabinoid system, which plays a role in regulating mood and stress. This unique mechanism may provide relief with potentially fewer side effects. Additionally, CBD offers a natural alternative, which could be appealing to those seeking options beyond conventional medications.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that cannabidiol (CBD) might help reduce PTSD symptoms. In one study, 91% of patients experienced a decrease in PTSD symptoms after taking CBD for eight weeks. Another study found that CBD helped with anxiety and depression, which often accompany PTSD. Some research suggests that while CBD provides short-term relief, it might not maintain reduced symptoms over the long term. In this trial, participants will be divided into groups to receive either a high dose or a low dose of CBD, or a placebo, to evaluate its effectiveness in managing PTSD symptoms. Overall, these findings suggest CBD could be a promising option for managing PTSD symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Esther M Blessing, MD PhD

Principal Investigator

NYU

Charles Marmar, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

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+

Brockman Foundation

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

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]

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]

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]

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., 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]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6482919/

Cannabidiol in the Treatment of Post-Traumatic Stress Disorder

Results: From the total sample of 11 patients, 91% (n = 10) experienced a decrease in PTSD symptom severity, as evidenced by a lower PCL-5 score at 8 weeks than ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04197102

Use of CBD Oil in the Treatment of Posttraumatic Stress ...

We predict that patients receiving CBD oil (CBD isolate or CBD Broad Spectrum) will show significantly greater improvement in PTSD symptoms and functional ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865424000176

Design and methodology of a pilot randomized clinical trial

Indeed, CBD monotherapy may provide short-term symptom relief, but may not be effective in maintaining long-term PTSD symptom reductions [31]. Collectively, ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37529155/

The Effectiveness and Adverse Events of Cannabidiol and ...

Conclusions: Formulations of cannabis significantly improved anxiety, depression, fatigue, and the ability to participate in social activities in participants ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid ...

The primary outcome will be change in PTSD symptoms as measured by change in the Clinician-Administered PTSD Scale (CAPS-5) total score. Official ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36154908/

Use of Cannabidiol (CBD) oil in the treatment of PTSD

This is the first placebo-controlled clinical trial investigating (a) CBD for the treatment of PTSD; and (b) the first study to test the relative efficacy of ...