CBD for Anxiety Disorders

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: McMaster University

Disqualifiers: Cannabis use, Substance use disorders, Schizophrenia, Bipolar, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CBD oil capsules to see if they can help adults aged 21-65 with specific anxiety disorders. CBD may reduce anxiety by interacting with brain chemicals that control mood and stress.

Will I have to stop taking my current medications?

You can continue taking your current psychotropic medications (like antidepressants or mood stabilizers) as long as the dose has been stable for 8 weeks before starting the trial. However, you must not change the dose during the study.

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

Research shows that CBD, a component of cannabis, has potential to help with anxiety disorders like generalized anxiety disorder and social anxiety disorder, especially when used for short periods. However, more studies are needed to understand its long-term effects and benefits in people with anxiety. ^{1 2 3 4 5}

Is CBD safe for treating anxiety disorders in humans?

Research suggests that CBD is generally safe for treating anxiety disorders, with most studies focusing on short-term use. However, more research is needed to understand the safety of long-term use in humans. ^{1 2 3 4 6}

How does the drug Cannabidiol (CBD) Oil Capsules differ from other treatments for anxiety disorders?

Cannabidiol (CBD) Oil Capsules are unique because they use CBD, a compound found in cannabis plants, which may help reduce anxiety by interacting with the body's endocannabinoid system (a network that helps regulate mood and stress). Unlike traditional anxiety medications, CBD is non-psychoactive, meaning it doesn't cause a 'high', and is taken orally in capsule form, offering a different administration route and potentially fewer side effects. ^{7 8 9 10 11}

Research Team

Michael Van Ameringen, MD, FRCPC

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

Adults aged 21-65 with Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Generalized Anxiety Disorder as per DSM-5 and a HAM-A score of ≥22. Must not use recreational cannabis during the study and have stable psychotropic medication doses for 8 weeks prior. Excludes pregnant women not using contraception, those with severe depression or suicidal behavior, family history of psychosis, adverse reactions to cannabis, substance abuse disorders (except tobacco), or certain mental disorders.

Inclusion Criteria

You are able to understand and comply with protocol requirements.

Concomitant psychotropic medication use will be allowed provided that the dose has been stable for 8 weeks prior to randomization. (including antidepressants, anti-psychotics, anti-convulsants, benzodiazepines, stimulants, mood stabilizers)

Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis of either GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score of ≥ 22

Exclusion Criteria

Participants with a lifetime history of daily cannabis use will be excluded

Dose changes of concomitant medication will not be permitted during the study period

Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive daily Cannabidiol (CBD) Oil Capsules or placebo for 8 weeks, with dose titration possible. Visits include assessments of side effects, mood, anxiety symptoms, and neuro-cognitive tasks.

8 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Cannabidiol (CBD) Oil Capsules

Trial Overview The trial is testing Cannabidiol (CBD) Oil Capsules against placebo over an 8-week period to see if they help reduce anxiety symptoms in adults with specific anxiety disorders. It will also look at how CBD affects inflammation and brain function related to anxiety.

Participant Groups

Group I: Cannabidiol (CBD) Oil Capsules Experimental Treatment 1 Intervention

Pure CBD in sunflower lecithin oil, flexibly dosed at 200-800 mg per day

Group II: Sunflower Lecithin Oil in Capsule Placebo Group 1 Intervention

1-4 capsules daily

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Tilray

Industry Sponsor

Trials

8

Recruited

250+

Findings from Research

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 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]

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]

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]

Laparoscopic common bile duct exploration has a high success rate of 94.6% in treating CBD stones, with only 1.4% of cases requiring conversion to open surgery, indicating its efficacy as a minimally invasive procedure.

The procedure has low complication rates, with minor complications occurring in 6.4% of patients and major complications in 3.8%, demonstrating its safety for patients undergoing this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic common bile duct exploration. Paganini, AM., Feliciotti, F., Guerrieri, M., et al.[2010]

The transcystic common bile duct (CBD) decompression cannula is a safe and effective alternative to T-tube insertion after laparoscopic CBD exploration, used in 12 patients without any instances of postoperative dislodgement.

This method allows for primary closure of the choledochotomy, potentially accelerating recovery and reducing hospital stays, with a median stay of 4 days, compared to traditional T-tube drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcystic biliary decompression after direct laparoscopic exploration of the common bile duct. Hensman, C., Crosthwaite, G., Cuschieri, A.[2019]

References

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

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

2. 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]

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

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Prospective trials in laparoscopic bile duct exploration. [2007]

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

Laparoscopic common bile duct exploration. [2010]

9. Germany pubmed.ncbi.nlm.nih.gov

Transcystic biliary decompression after direct laparoscopic exploration of the common bile duct. [2019]

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

Laparoscopic cholecystectomy and common bile duct exploration are safe for older patients. [2023]

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

Training higher surgical trainees in laparoscopic common bile duct exploration. [2021]