What side effects are associated with this type of intervention?

Common treatments for Generalized Anxiety Disorder (GAD) that are similar to Cannabidiol (CBD) Oil Capsules include other anxiolytics such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and benzodiazepines. SSRIs and SNRIs can cause side effects like nausea, insomnia, dizziness, dry mouth, and sexual dysfunction. Benzodiazepines, while effective for short-term relief, can lead to drowsiness, dizziness, and dependency with long-term use. CBD oil, specifically, has been associated with side effects such as transient cognitive impairment, drowsiness, impaired attention, and nausea, with a higher risk of dizziness.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Generalized Anxiety Disorder (GAD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). These include drugs like sertraline, fluoxetine, and duloxetine, which are known for their anxiolytic effects. While these medications do not have the anti-inflammatory properties of Cannabidiol (CBD), they are effective in managing anxiety symptoms. Currently, there is limited evidence and no FDA approval for the use of CBD oil specifically for GAD, although ongoing studies are exploring its potential benefits.

What other types of research exist?

Promising alternatives to CBD Oil Capsules for GAD patients include: 1) FAAH inhibitors, which have shown potential in treating pain and depression, indicating possible anxiolytic effects. 2) Selective serotonin reuptake inhibitors (SSRIs) like citalopram and paroxetine, which are well-established for anxiety and have anti-inflammatory properties. 3) Other cannabinoids such as THC:CBD extracts, which have been studied for their analgesic and anxiolytic effects. Consulting with a healthcare provider is essential to tailor the treatment to individual needs.

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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

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

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 more

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

Do I qualify?Apply below to find out

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.

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Who is running the clinical trial?

TilrayIndustry Sponsor

7 Previous Clinical Trials

195 Total Patients Enrolled

McMaster UniversityLead Sponsor

891 Previous Clinical Trials

2,605,416 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

Cannabidiol (CBD) Oil Capsules (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03549819 — Phase 3

Generalized Anxiety Disorder Research Study Groups: Sunflower Lecithin Oil in Capsule, Cannabidiol (CBD) Oil Capsules

Generalized Anxiety 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

~15 spots leftby Jun 2025

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