CBD for Anxiety

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Florida

Must not be taking: Benzodiazepines, Opioids, Antihistamines, others

Disqualifiers: Pregnancy, Suicidal behavior, Liver disease, others

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg/day of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you've changed your SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of the baseline visit. You also need to refrain from using certain medications like benzodiazepines, opioids, and antihistamines, among others, during the trial.

What data supports the effectiveness of the drug CBD for anxiety?

Research shows that CBD, a component of cannabis, can help reduce anxiety. In a study with healthcare workers, CBD significantly lowered anxiety levels, and these effects lasted even after stopping the treatment. ^{1 2 3 4 5}

Is CBD safe for human use?

CBD is generally considered safe for human use, but some studies have reported adverse effects like mental and liver disorders, especially when used with other medications. More research is needed to fully understand its safety, particularly regarding reproductive and developmental health. ^{3 6 7 8 9}

How does the drug CBD differ from other treatments for anxiety?

CBD is unique because it is a non-psychoactive component of cannabis that may help reduce anxiety by affecting the endocannabinoid system, which is different from traditional anxiety medications that often target neurotransmitters like serotonin. Unlike some other treatments, CBD is also being studied for its potential to help with sleep disturbances that often accompany anxiety. ^{3 4 10 11 12}

Research Team

Eligibility Criteria

Adults aged 18-55 with moderate to severe anxiety, as indicated by a HAM-A score over 14. Participants must be willing to give informed consent, follow study procedures including blood donation, and use two effective contraception methods if of childbearing potential.

Inclusion Criteria

I am between 18 and 55 years old.

My anxiety level is moderate to severe, according to the HAM-A scale.

Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation

Exclusion Criteria

I do not have any unstable medical or neurological conditions.

Positive drug screen for substances of abuse

I have experienced severe depression symptoms in the last six months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a hemp-derived CBD product for improving anxiety symptoms and sleep disturbances. The treatment period consists of a two-week titration period followed by a 2-week maintenance period.

4 weeks

Weekly visits for monitoring and dose adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and changes in anxiety and sleep quality.

8 weeks

Periodic assessments over 8 weeks

Treatment Details

Interventions

• Hemp Derived Cannabidiol Extract (Cannabinoid)

Trial Overview The trial is testing the safety and preliminary effectiveness of hemp-derived CBD for reducing anxiety symptoms and sleep disturbances. It's a randomized, double-blind study comparing CBD doses (50-150 mg/day) against placebo over four weeks.

Participant Groups

Group I: Hemp Derived Cannabidiol Extract Experimental Treatment 1 Intervention

SunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo substance to reflect same consistency as the experimental drug

Hemp Derived Cannabidiol Extract is already approved in Canada for the following indications:

Approved in Canada as Cannabidiol for:

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

Findings from Research

About 31.3% of parents surveyed reported giving unlicensed cannabidiol (CBD) products to their children diagnosed with ADHD, autism spectrum disorder (ASD), or generalized anxiety disorder (GAD), indicating a significant prevalence of CBD use in this population.

Parents who used CBD products generally perceived them as safer and felt more community support for their use, suggesting a need for healthcare providers to discuss the safety and implications of CBD use with families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Perceptions and Usage of Unlicensed Cannabidiol Products in Children With Anxiety and Neurodevelopmental Disorders. Schwaller, K., Krauss, Z., Chen, AMH., et al.[2023]

A 28-day treatment with 300 mg of Cannabidiol (CBD) significantly reduced anxiety levels in frontline healthcare workers during the COVID-19 pandemic, with effects observed up to one month after stopping the treatment.

The study suggests that CBD may provide lasting anxiolytic benefits, but further double-blind placebo-controlled trials are necessary to confirm these findings and assess any potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintained anxiolytic effects of cannabidiol after treatment discontinuation in healthcare workers during the COVID-19 pandemic. Souza, JDS., Zuardi, AW., Guimarães, FS., et al.[2022]

In a study comparing the effects of cannabidiol (CBD) on anxiety in male and female rats, it was found that female rats showed a significant response to CBD only during the late diestrus phase of their estrous cycle, requiring a much lower dose than males.

Both sexes exhibited anxiolytic-like effects from CBD, but the differences in responsiveness suggest that hormonal fluctuations in females may influence the drug's effectiveness, highlighting the need for sex-specific considerations in CBD treatment for anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. Fabris, D., Carvalho, MC., Brandão, ML., et al.[2023]

Chronic administration of cannabidiol (CBD) in rats led to increased anxiety-like behavior, as indicated by more time spent freezing in a conditioned emotional response test, contrasting with previous findings of acute anxiolytic effects.

CBD also decreased the expression of brain-derived neurotrophic factor (BDNF) and its receptor TrkB in the hippocampus, suggesting that chronic CBD treatment may negatively impact brain protein levels associated with anxiety and depression, which is opposite to the effects seen with traditional antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiogenic-like effects of chronic cannabidiol administration in rats. ElBatsh, MM., Assareh, N., Marsden, CA., et al.[2021]

In a 12-week open-label trial involving 31 young people aged 12-25 with treatment-resistant anxiety disorders, cannabidiol (CBD) significantly reduced anxiety severity by 42.6%, as measured by the Overall Anxiety Severity and Impairment Scale (OASIS).

CBD was found to have an adequate safety profile, with 80.6% of participants reporting mild adverse events like fatigue and low mood, but no serious or unexpected adverse events were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. Berger, M., Li, E., Rice, S., et al.[2022]

A systematic review of eight studies, including six randomized controlled trials, suggests that cannabidiol (CBD) may be effective in reducing anxiety symptoms in various anxiety disorders, with doses ranging from 6 mg to 400 mg.

CBD was generally well-tolerated with minimal side effects, primarily fatigue and sedation, indicating its potential as a safe alternative therapy for anxiety management, although further research is needed for standardized dosing and efficacy assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cannabidiol in anxiety and anxiety-related disorders. Skelley, JW., Deas, CM., Curren, Z., et al.[2022]

In a large survey of over 45,000 participants from the U.S. and Canada, CBD product use was more common in the U.S. (26.1%) compared to Canada (16.2%), with a variety of products being used for managing pain, anxiety, and depression.

Despite widespread use, over half of the consumers reported benefits from CBD oil, highlighting a need for clearer public health messaging about its therapeutic effects, especially since many reported conditions lack strong evidence for CBD efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and Perceptions of Cannabidiol Products in Canada and in the United States. Goodman, S., Wadsworth, E., Schauer, G., et al.[2023]

Repeated administration of cannabidiol (CBD) over 21 days significantly reduces panic-like escape responses in rats, indicating its potential as an anti-panic treatment.

The anti-panic effects of CBD are mediated through the activation of 5-HT1A receptors in the dorsal periaqueductal gray (DPAG), as blocking these receptors prevents CBD's effects, although CBD does not alter serotonin levels or receptor expression in this brain region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involvement of serotonin-mediated neurotransmission in the dorsal periaqueductal gray matter on cannabidiol chronic effects in panic-like responses in rats. Campos, AC., de Paula Soares, V., Carvalho, MC., et al.[2021]

Cannabidiol (CBD) has shown greater anxiolytic effects in healthy individuals and certain clinical populations, but it does not significantly impact sleep, indicating its potential as an anxiety treatment.

The effectiveness of CBD appears to be influenced by dosage and its ratio to THC in combined treatments, with its action primarily modulating the endocannabinoid system and regulating neuroendocrine function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabinoid treatments for anxiety: A systematic review and consideration of the impact of sleep disturbance. Narayan, AJ., Downey, LA., Manning, B., et al.[2022]

References

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

Parental Perceptions and Usage of Unlicensed Cannabidiol Products in Children With Anxiety and Neurodevelopmental Disorders. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Maintained anxiolytic effects of cannabidiol after treatment discontinuation in healthcare workers during the COVID-19 pandemic. [2022]

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

Sex-dependent differences in the anxiolytic-like effect of cannabidiol in the elevated plus-maze. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Anxiogenic-like effects of chronic cannabidiol administration in rats. [2021]

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

Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial. [2022]

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

Use of cannabidiol in anxiety and anxiety-related disorders. [2022]

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

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

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

Use and Perceptions of Cannabidiol Products in Canada and in the United States. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Involvement of serotonin-mediated neurotransmission in the dorsal periaqueductal gray matter on cannabidiol chronic effects in panic-like responses in rats. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

The effects of cannabidiol on worry and anxiety among high trait worriers: a double-blind, randomized placebo controlled trial. [2023]

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

Cannabinoid treatments for anxiety: A systematic review and consideration of the impact of sleep disturbance. [2022]