Cannabidiol for Anxiety

Study Overview
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Brief Summary
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This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.

Official Title
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Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Cannabidiol


Participation Criteria
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Eligibility Criteria
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Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater Presenting to a participating clinic for initial evaluation for a medical cannabis card Willingness to abstain from the use of all other cannabis products for the trial period (3 months) Not pregnant or planning to become pregnant during the trial period (3 months) Not breastfeeding or planning to breastfeed during the trial period (3 months) No history of cannabis use within 4 weeks of enrollment No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder) No history of lifetime daily cannabis use No family history of psychosis (e.g., bipolar disorder or schizophrenia) No history of adverse reactions to cannabis No recent changes to prescribed anxiety medications (within the last 1 month) Provision of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol<br>Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks. | Drug: Cannabidiol<br>* 25 mg full-spectrum CBD soft gel capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder 7-item scale is one of the most frequently used, validated self-reported questionnaires that is used to screen for, diagnose, and assess severity of generalized anxiety disorder. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of change | Participants will complete the Patients' Global Impression of Change (PGIC) scale at each follow-up visit, which has been regarded as an important self-reported indicator of change. | 12 weeks | 
| Protocol Compliance | Participants will self-report their intervention compliance using a simple log that will be provided to them at their enrollment visit and will be asked to bring their CBD log to every follow-up visit. Participants will also self-report any medical cannabis or opioid usage. | 12 weeks | 
| Sleep quality | Participants will be asked whether they believe that the CBD intervention has impacted their sleep quality. They will be asked to complete a short 2-question survey. | 12 weeks |