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Stopped due to COVID-19 pandemic.
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| Name | Class |
|---|---|
| Green Lotus Hemp | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Experimental | Participants will take 25 mg full-spectrum CBD soft gel capsules (2 to 4 per day) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | 25 mg full-spectrum CBD soft gel capsules |
|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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 |