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Cannabinoid

CBD for Anxiety Disorders

Phase 3
Recruiting
Led By Michael Van Ameringen, MD, FRCPC
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects are not detailed here, common ones associated with CBD may include tiredness, diarrhea, changes in appetite/weight. Since it's being tested under medical supervision any unexpected side effects would be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hamilton Anxiety Rating Scale (HAM-A)
Secondary study objectives
Clinical Global Impression - Improvement (CGI-I)
Clinical Global Impression - Severity (CGI-S)
Digits Backward Test
+24 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cannabidiol (CBD) Oil CapsulesExperimental Treatment1 Intervention
Pure CBD in sunflower lecithin oil, flexibly dosed at 200-800 mg per day
Group II: Sunflower Lecithin Oil in CapsulePlacebo Group1 Intervention
1-4 capsules daily

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Generalized Anxiety Disorder (GAD) include benzodiazepines, SSRIs, and SNRIs. Benzodiazepines work by enhancing the effect of GABA, a neurotransmitter that induces relaxation and reduces anxiety. SSRIs and SNRIs increase serotonin and norepinephrine levels in the brain, which helps improve mood and reduce anxiety. Cannabidiol (CBD) is believed to interact with the endocannabinoid system, which regulates mood, stress, and inflammation. Understanding these mechanisms helps in creating effective treatment plans for GAD patients, potentially improving outcomes and minimizing side effects.

Find a Location

Who is running the clinical trial?

TilrayIndustry Sponsor
7 Previous Clinical Trials
198 Total Patients Enrolled
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,209 Total Patients Enrolled
2 Trials studying Panic Disorder
60 Patients Enrolled for Panic Disorder
Michael Van Ameringen, MD, FRCPCPrincipal InvestigatorHamilton Health Sciences Corporation
10 Previous Clinical Trials
752 Total Patients Enrolled
3 Trials studying Panic Disorder
230 Patients Enrolled for Panic Disorder

Media Library

Cannabidiol (CBD) Oil Capsules (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03549819 — Phase 3
Panic Disorder Research Study Groups: Sunflower Lecithin Oil in Capsule, Cannabidiol (CBD) Oil Capsules
Panic Disorder Clinical Trial 2023: Cannabidiol (CBD) Oil Capsules Highlights & Side Effects. Trial Name: NCT03549819 — Phase 3
Cannabidiol (CBD) Oil Capsules (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03549819 — Phase 3
~13 spots leftby Nov 2025