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

Trial Summary

What is the purpose of this trial?

To examine the extent to which Cannabidiol (CBD) enhances fear conditioning extinction in college undergraduates who show elevated social anxiety. Undergraduates who display elevated social anxiety on standard assessments will be recruited at the University of Connecticut. All participants will be put in a standard fear conditioning paradigm where they are conditioned to fear a face that occasionally is followed by a shock to their wrist. The other face never is paired with a shock. After everybody learns this, half of the participants will receive 600 mg CBD Isolate Gel Capsules one time, and the other half will receive a placebo dose. Participants will then be presented with the faces with no shocks, and the rate and duration of extinction as measured by electrodermal response as well as subjective fear ratings via a visual analogue scale will be examined. It is hypothesized that participants that receive CBD will display enhanced extinction compared to the placebo group, as evidenced by reduced electrodermal response and reduced visual analogue fear ratings.

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.

What data supports the effectiveness of the drug Cannabidiol Oral Product for anxiety disorders?

Research suggests that cannabidiol (CBD) can help reduce anxiety by decreasing fear and enhancing the process of overcoming fear, which is promising for treating anxiety-related conditions like phobias and PTSD. ^{1 2 3 4 5}

Is cannabidiol (CBD) safe for humans?

Research suggests that cannabidiol (CBD) is generally safe for humans, with studies indicating it can reduce anxiety and fear without causing significant side effects. However, most studies focus on short-term use, and more research is needed to understand its long-term safety. ^{1 2 4 6 7}

How does the drug Cannabidiol differ from other treatments for anxiety disorders?

Cannabidiol (CBD) is unique because it is a non-psychoactive component of cannabis that shows potential for treating various anxiety disorders, but most studies focus on its short-term effects rather than long-term use. Unlike many traditional anxiety medications, CBD is derived from a natural source and is being explored for its broad therapeutic potential, though more research is needed on its chronic use. ^{1 2 6 8 9}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

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

Prohedonic Effect of Cannabidiol in a Rat Model of Depression. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cannabidiol Regulation of Learned Fear: Implications for Treating Anxiety-Related Disorders. [2020]

5. United States 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. [2023]

6. 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]

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

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

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

The effects of cannabidiol on persecutory ideation and anxiety in a high trait paranoid group. [2022]

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

Cannabidiol as a Potential Treatment for Anxiety Disorders. [2018]