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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
Study Summary
This trial will test if Cannabidiol (CBD) Oil Capsules can help treat symptoms of anxiety disorders. It will also look at how CBD affects inflammation and neuro-cognition.
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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hamilton Anxiety Rating Scale (HAM-A)
Secondary outcome measures
Clinical Global Impression - Improvement (CGI-I)
Clinical Global Impression - Severity (CGI-S)
Digits Backward Test
+24 moreTrial 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
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Who is running the clinical trial?
TilrayIndustry Sponsor
7 Previous Clinical Trials
195 Total Patients Enrolled
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,778 Total Patients Enrolled
3 Trials studying Generalized Anxiety Disorder
190 Patients Enrolled for Generalized Anxiety Disorder
Michael Van Ameringen, MD, FRCPCPrincipal InvestigatorHamilton Health Sciences Corporation
10 Previous Clinical Trials
752 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
60 Patients Enrolled for Generalized Anxiety Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to understand and comply with protocol requirements.You cannot currently use cannabis for recreational or medicinal purposes within 4 weeks of starting the study.If you have a history of having problems with using cannabis or other substances (except for tobacco), you will not be able to participate.You have been diagnosed with certain mental disorders like schizophrenia, bipolar disorder, or intellectual disability. However, if you have obsessive compulsive disorder or posttraumatic stress disorder and it is the main issue, you may still be able to participate.You are between 21-65 years old and have been diagnosed with GAD, SAD, PD, or agoraphobia by a doctor using DSM-5 criteria. You also have a HAM-A score of at least 22.
Research Study Groups:
This trial has the following groups:- Group 1: Sunflower Lecithin Oil in Capsule
- Group 2: Cannabidiol (CBD) Oil Capsules
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients who are 65 years or older able to participate in this clinical trial?
"The eligibility requirements state that potential patients must be aged 21-65."
Answered by AI
Are there any remaining vacancies for participants in this trial?
"No, this clinical trial is not recruiting at the moment. This information can be found on clinicaltrials.gov; the trial was first posted on April 1st 2021 and was last updated on March 22nd 2021. There are 1372 other trials that are actively looking for patients."
Answered by AI
Does the FDA have any official stance on CBD oil pills?
"There is pre-existing clinical data supporting the safety of Cannabidiol (CBD) Oil Capsules, so it received a score of 3."
Answered by AI
What is the sample size of this clinical trial?
"This study is not looking for new participants at the moment. According to the latest update on clinicaltrials.gov, this trial was posted on April 1st 2021 and last updated on March 22nd 2021. If you are interested in other trials, there are 1285 studies for agoraphobia and 87 CBD Oil Capsules trials that are still open for enrollment."
Answered by AI
Are Cannabidiol (CBD) Oil Capsules a new medication?
"There are currently 87 ongoing clinical trials for Cannabidiol (CBD) Oil Capsules, with 19 of those being in the third and final stage. Many of these studies are based in Brazil, more specifically Ribeirao Preto and Sao Paulo. However, there are a total of 322 locations running trials for this potential medication."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
MacAnxiety Research Centre
How many prior treatments have patients received?
3+
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