Cannabidiol for Anxiety Disorders

Overseen By Robert Astur, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Connecticut

Must not be taking: CBD, Cannabis

Disqualifiers: Heart problems, Neurological disorders, others

Compensation: Varies

Number of Visits: 3

Duration: 1 session

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how Cannabidiol (CBD), a compound in cannabis, might help college students with high social anxiety reduce their fear responses. Participants will view images they initially learned to fear, but this time without any shocks. Some participants will take a one-time Cannabidiol Oral Product (CBD capsule), while others will receive a placebo to determine if CBD reduces fear. Ideal candidates are undergraduates at the University of Connecticut who frequently experience social anxiety and meet specific health criteria. As an Early Phase 1 trial, this study aims to understand how CBD works in people, offering participants an opportunity to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken CBD or any cannabis product in the last 24 hours 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 people, but some concerns remain. In studies on CBD for anxiety, most participants tolerated it well. However, limited information exists about its effects on the liver, especially at lower doses. Some studies have shown mixed results regarding changes in liver enzymes, which can indicate liver stress.

The FDA has already approved CBD for other conditions at higher doses than those used in some anxiety studies. This suggests it might be safe, but individual reactions can vary. Participants in studies should monitor their health and report any unusual symptoms to the research team. ^{1 2 3 4 5}

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

Most treatments for anxiety disorders involve medications like SSRIs or benzodiazepines, which primarily target neurotransmitters like serotonin. But cannabidiol (CBD) works differently, interacting with the body's endocannabinoid system to potentially reduce anxiety without the risk of dependency. Researchers are excited about CBD because it's a natural compound derived from cannabis, offering a new approach that could bypass some side effects associated with traditional anxiety medications. Plus, CBD is being explored for its potential to deliver rapid relief, offering hope for those who need faster-acting anxiety management.

What evidence suggests that Cannabidiol might be an effective treatment for anxiety?

Research shows that cannabidiol (CBD), which participants in this trial may receive, might help reduce anxiety. Studies have found that CBD can ease symptoms in various anxiety disorders, such as social anxiety disorder (SAD). One study discovered that CBD lowered anxiety with fewer side effects than a placebo. Another study noted that CBD improved anxiety, depression, and social skills. While results can differ, overall evidence suggests that CBD could be a useful treatment for anxiety disorders. Participants in this trial will receive either CBD or a placebo to evaluate its effectiveness. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for college undergraduates aged 18-50 at the University of Connecticut who show high levels of social anxiety. Participants must not have any conditions that would exclude them from safely receiving CBD or a placebo.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants undergo a fear conditioning paradigm where they learn to fear a face associated with a shock

1 session

1 visit (in-person)

Treatment

Participants receive a one-time dose of either 600 mg CBD or placebo and are exposed to the faces without shocks

1 session

1 visit (in-person)

Follow-up

Participants are monitored for electrodermal response and subjective fear ratings

20 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol Oral Product
• Placebo

Trial Overview The study tests if a single dose of Cannabidiol (CBD) can help reduce fear and anxiety compared to a placebo. It measures how participants respond to faces associated with mild shocks after taking either CBD or a sugar pill, without further shocks.

How Is the Trial Designed?

Group I: Cannabidiol Experimental Treatment 1 Intervention

600 mg Cannabidiol Isolate Gel Capsules / participant. One-time dose.

Group II: Placebo Placebo Group 1 Intervention

Same number of placebo capsules / participant. One-time dose.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Published Research Related to This Trial

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 study involving 63 individuals with high levels of worry, a single acute dose of 300mg of cannabidiol (CBD) did not significantly reduce worry severity or anxiety symptoms, indicating that CBD may not effectively target cognitive aspects of anxiety.

However, after a 2-week period of repeated administration, the 300mg dose of CBD did show a reduction in physical anxiety symptoms compared to placebo, suggesting that CBD may have modest effects on the physical manifestations of anxiety rather than cognitive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cannabidiol on worry and anxiety among high trait worriers: a double-blind, randomized placebo controlled trial. Gournay, LR., Ferretti, ML., Bilsky, S., 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 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]

A systematic review of 87 studies found that cannabidiol (CBD) had no effect on anxiety outcomes in 70.3% of observations, indicating that its efficacy for anxiety reduction may not be consistent across different studies and species.

There was no clear relationship between CBD drug levels and anxiety outcomes, suggesting that dosing recommendations for anxiety treatment cannot be straightforwardly established and further research is needed to clarify its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool. Kwee, CM., van Gerven, JM., Bongaerts, FL., et al.[2023]

In a study involving 96 male rats (48 WKY rats with depressive-like behaviors and 48 control Wistar rats), cannabidiol (CBD) demonstrated a significant prohedonic effect at a dose of 30 mg/kg, suggesting its potential as an antidepressant.

CBD also improved motivation and exploration behaviors in WKY rats at doses of 15 mg/kg and 45 mg/kg, indicating its possible efficacy in treating conditions characterized by low motivation and anhedonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prohedonic Effect of Cannabidiol in a Rat Model of Depression. Shoval, G., Shbiro, L., Hershkovitz, L., et al.[2022]

Citations

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

Therapeutic potential of cannabidiol (CBD) in anxiety ... This meta-analysis focuses on the efficacy of CBD in treating anxiety disorders such as generalized anxiety disorder (GAD), social anxiety disorder (SAD), and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11595441/

The Impact of Cannabidiol Treatment on Anxiety Disorders Despite these conflicting outcomes, the data suggest that CBD may reduce anxiety with minimal adverse effects when compared to a placebo.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10387818/

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 ...

4. nature.com nature.com/articles/s43856-022-00202-8

open-label data from a two-stage, phase 2 clinical trial Conclusions. Results provide preliminary evidence supporting efficacy and tolerability of a full-spectrum, high-CBD product for anxiety.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06672666

NCT06672666 | Use of CBD in the Treatment of Anxiety This study will examine the safety and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31866386/

Use of cannabidiol in anxiety and anxiety-related disorders The purpose of this systematic review was to evaluate the current evidence on the safety and efficacy of CBD in anxiety and anxiety-related disorders. Data ...

7. fda.gov fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trial

CDER Investigators Address the Safety of CBD in a ... Liver safety data are limited for lower CBD doses and inconsistent regarding the occurrence and severity of liver enzyme elevations at 200-400 ...

8. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Many concerns have been raised about CBD use, particularly with regard to over-the-counter. CBD products, as there are limited data on their safety and ...