CBD for PTSD

Recruiting at 1 trial location

Overseen By Matthew Rizzo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Nebraska

Must not be taking: CBD products, Anti-viral HIV

Disqualifiers: Substance use disorder, Psychosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).

Do I have to stop taking my current medications for the CBD for PTSD trial?

The trial requires that your current medications for PTSD be stable for at least 4 weeks before joining. If you're taking any prescribed or commercially available CBD products, you must stop those before participating.

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

Research suggests that CBD may help with PTSD by affecting the endocannabinoid system, which is involved in processing emotional memories. Studies in animals and some human trials have shown that CBD can help reduce anxiety and improve symptoms by altering how traumatic memories are stored and recalled. ^{1 2 3 4 5}

Is CBD safe for humans?

CBD, also known as Epidiolex, has been studied for safety in humans, including healthy adults and those with conditions like Dravet and Lennox-Gastaut syndromes. It is generally considered safe, but as with any treatment, it is important to discuss with a healthcare provider. ^{1 4 5 6 7}

How does the drug Cannabidiol (CBD) differ from other treatments for PTSD?

Cannabidiol (CBD) is unique because it targets the endocannabinoid system, which is involved in regulating fear memory and anxiety, unlike traditional PTSD treatments that often focus on serotonin levels. CBD is a non-psychotomimetic compound, meaning it doesn't cause the 'high' associated with cannabis, and it has shown potential in preclinical studies to help with PTSD symptoms by modulating fear learning and memory. ^{1 4 5 7 8}

Research Team

Matthew Rizzo, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

Adults aged 21-65 with PTSD, having symptoms for at least a month and a certain score on the CAPS-5 scale. Participants must be stable on current treatments for 4 weeks, drive regularly, and have good vision. Excluded are those using CBD products or other drugs excessively, pregnant or breastfeeding women, people with severe medical conditions or recent suicide attempts.

Inclusion Criteria

All Subjects: THC use must be less than 3 days per week

All Subjects: Able to read and communicate in English

I am willing and able to follow all study procedures for its duration.

Exclusion Criteria

All Subjects: Positive urine drug screen for illicit substances other than cannabis

All Subjects: Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)

My PTSD is due to trauma experienced before I was 18, with no other related traumas.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Subjects complete 3 weeks of baseline data collection including assessments of activity and sleep

3 weeks

1 visit (in-person)

Treatment

Participants receive Nantheia ATL5 or placebo, initiated at 400mg BID and maintained over 8 weeks

8 weeks

Multiple visits (in-person) for assessments and laboratory testing

Follow-up

Safety measures including laboratory testing, assessment of AE's and CSSRS-R are repeated one week after treatment withdrawal

1 week

1 visit (in-person)

Treatment Details

Interventions

• Cannabidiol (CBD)

Trial Overview The trial tests Cannabidiol (CBD) Nantheia ATL5 against a placebo in adults with PTSD over an 8-week period. Starting at 400mg twice daily after baseline data collection of sleep and activity levels. It includes symptom assessments, lab tests for inflammatory markers, clinician evaluations, and optional driving and brain imaging studies.

Participant Groups

Group I: Cannabidiol Administered as Nantheia ATL5 Group Experimental Treatment 1 Intervention

Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg will be administered twice a day in 100mg softgel capsules to CBD Group. Each 100mg softgel contains 10% CBD.

Group II: Control Group Active Control 1 Intervention

Baseline data collection only will be collected from Control group.

Group III: Placebo Group Placebo Group 1 Intervention

Matching placebo capsules will be administered twice a day to Placebo Group.

Cannabidiol (CBD) is already approved in United States, European Union 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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Ananda Scientific Inc

Collaborator

Trials

1

Recruited

180+

Findings from Research

In a mouse model of PTSD, cannabidiol (CBD) significantly reduced PTSD-like symptoms by affecting trauma-related fear memory and anxiety behaviors, showing its potential as a treatment option.

Unlike the antidepressant sertraline, which was only effective when given before exposure to fear, CBD was effective regardless of when it was administered, indicating a broader mechanism of action in fear memory processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between cannabidiol and sertraline for the modulation of post-traumatic stress disorder-like behaviors and fear memory in mice. Han, X., Song, X., Song, D., et al.[2022]

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) shows promise as a treatment for post-traumatic stress disorder (PTSD) by facilitating the extinction of aversive memories and blocking their reconsolidation, based on preclinical studies in rodents.

Recent human studies have confirmed that CBD can significantly improve PTSD symptoms, highlighting its potential as a safer alternative to current pharmacological therapies, which often have limited efficacy and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Therapeutic Alternative for Post-traumatic Stress Disorder: From Bench Research to Confirmation in Human Trials. Bitencourt, RM., Takahashi, RN.[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]

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]

Pure, plant-derived cannabidiol (CBD; Epidiolex) has been shown to significantly reduce seizure frequencies in patients with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) by 17% to 23% compared to placebo, making it an effective adjunctive therapy for treatment-resistant epilepsy.

CBD is generally well tolerated, with common side effects including somnolence, diarrhea, and elevated liver enzymes, and it is the first cannabis-derived medication approved by the FDA for these conditions, providing a new treatment option for patients aged 2 years and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes. Chen, JW., Borgelt, LM., Blackmer, AB.[2020]

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.

CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. Crockett, J., Critchley, D., Tayo, B., et al.[2021]

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. Germany pubmed.ncbi.nlm.nih.gov

Comparison between cannabidiol and sertraline for the modulation of post-traumatic stress disorder-like behaviors and fear memory in mice. [2022]

2. 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]

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

Cannabidiol as a Therapeutic Alternative for Post-traumatic Stress Disorder: From Bench Research to Confirmation in Human Trials. [2020]

4. 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]

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

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

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

Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes. [2020]

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

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. [2021]

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

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