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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Cannabidiol (CBD) Oil Capsules can reduce symptoms in people with anxiety disorders. Researchers compare CBD oil to a placebo to better understand its effectiveness. They also investigate how CBD might affect inflammation and brain function in individuals with anxiety. Those diagnosed with a primary anxiety disorder, such as generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia, and who can manage daily life without recreational cannabis, might be suitable for this study. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that Cannabidiol (CBD) Oil Capsules are likely to be safe for humans?

Research shows that CBD (Cannabidiol) is under study for its safety and effectiveness in treating anxiety. Some studies suggest that people generally tolerate CBD well. However, concerns exist about its effects on the liver, particularly at higher doses. Liver enzyme levels can change, but this varies among individuals. Most studies have examined lower doses than those planned for this trial.

While CBD is often considered safe, more research is needed to fully understand its effects, especially with larger amounts over time. Prospective trial participants should weigh the potential benefits and risks. Consulting a healthcare provider before starting a new treatment is crucial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for anxiety disorders, which often include medications like SSRIs or benzodiazepines, cannabidiol (CBD) oil offers a unique approach by utilizing a natural compound found in cannabis. Researchers are excited about CBD because it targets the endocannabinoid system, which plays a role in regulating mood and stress responses, potentially offering relief without the side effects associated with traditional medications. Additionally, the flexible dosing of CBD oil capsules, ranging from 200-800 mg per day, allows for personalized treatment tailored to individual needs, which could enhance its effectiveness and tolerability compared to conventional options.

What evidence suggests that Cannabidiol (CBD) Oil Capsules might be an effective treatment for anxiety disorders?

Research has shown that CBD oil capsules, which participants in this trial may receive, can help reduce anxiety. A review of several studies found that CBD effectively treats anxiety disorders such as generalized anxiety disorder (GAD) and social anxiety disorder (SAD). Earlier studies suggested that CBD can lower anxiety levels with few side effects compared to a placebo. Additionally, CBD products have improved anxiety, depression, and social participation. Overall, the evidence supports CBD as a promising treatment for anxiety disorders. ^{4 5 6 7 8}

Who Is on the Research Team?

Michael Van Ameringen, MD, FRCPC

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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. 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.

3. 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.

4. 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 ...

5. 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 ...

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 ...