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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cannabidiol (CBD) can alleviate symptoms in adults with post-traumatic stress disorder (PTSD). PTSD can lead to flashbacks, sleep disturbances, and heightened anxiety following a traumatic event. Participants will take either a CBD softgel or a placebo (a pill with no active ingredient) for eight weeks to assess symptom improvement. This trial may suit adults diagnosed with PTSD who have experienced symptoms for at least a month. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cannabidiol (CBD) is generally safe for use. In past studies, participants taking CBD for PTSD experienced few side effects, with the most common being mild fatigue and changes in appetite.

CBD has been used in other treatments and studied for various conditions, providing extensive safety information. Its history of testing in people adds confidence in its safety.

In this trial, CBD is administered in a specific form called Nantheia ATL5. Although this is a unique version, the overall safety record of CBD supports its use. Individual experiences may vary, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike the standard treatments for PTSD, which often include medications like SSRIs or SNRIs, the use of cannabidiol (CBD) offers a novel approach by targeting the body's endocannabinoid system. Researchers are excited about CBD because it is derived from cannabis and is thought to have anti-anxiety and anti-inflammatory properties without the psychoactive effects associated with THC. Additionally, this particular formulation, Nantheia ATL5, is administered in a liquid structure softgel that may enhance absorption and ensure consistent dosing. This could potentially lead to quicker and more stable relief from PTSD symptoms compared to traditional oral medications.

What evidence suggests that this treatment might be an effective treatment for PTSD?

Research has shown that CBD might help reduce PTSD symptoms. In one study, 91% of participants reported less severe PTSD symptoms after using CBD for eight weeks. Another study found that CBD significantly reduced anxiety, often linked to PTSD. However, some research suggests CBD might only provide short-term relief for PTSD symptoms. This trial will evaluate the effects of Cannabidiol (CBD) administered as Nantheia ATL5 in one of the treatment arms. Overall, early findings are promising, but more research is needed to understand its long-term effectiveness. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew Rizzo, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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: Able to read and communicate in English

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

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

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

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)

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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 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]

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 ... The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic stress disorder using a rigorous ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10884801/

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].

4. sciencedirect.com sciencedirect.com/science/article/pii/S0165178124003342

Therapeutic potential of cannabidiol (CBD) in anxiety ... Our meta-analysis provides further support for the anxiolytic effects of CBD, revealing statistically significant reductions in anxiety symptoms across various ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14737175.2022.2155139

analysis from the UK Medical Cannabis Registry Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry. Manaswini Pillai ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04197102

Use of CBD Oil in the Treatment of Posttraumatic Stress ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... No current medical problems that would preclude safe ingestion of CBD oil 11.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002592

Use of Cannabidiol (CBD) oil in the treatment of PTSD This will be the first randomized placebo-controlled trial to evaluate the clinical benefits of CBD in the treatment of posttraumatic stress disorder.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04550377

Cannabidiol as a Treatment for PTSD and PTSD Comorbid ... This will be a randomized placebo controlled study to test the efficacy of cannabidiol (CBD) as a treatment for symptoms of post-traumatic ...