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| ID | Type | Description | Link |
|---|---|---|---|
| RADX-2021-002 | Other Identifier | Radicle |
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A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.
Radicle ACES is a real-world evidence study that aims to determine the effect of CBD on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Commercially available, orally ingestible CBD product A |
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| Arm B | Commercially available, orally ingestible CBD product B |
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| Arm C | Commercially available, orally ingestible CBD product C |
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| Arm D | Commercially available, orally ingestible CBD product D |
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| Arm E | Commercially available, orally ingestible CBD product E |
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| Arm F | Commercially available, orally ingestible CBD product F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercially available, orally ingestible CBD product | Other | botanically-derived CBD extract product |
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| Measure | Description | Time Frame |
|---|---|---|
| Greater increase in overall well-being from baseline | Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL) | 4 weeks |
| Improvement in overall well-being from baseline | Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being) | 4 weeks |
| Change in overall well-being from baseline | Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in sleep from baseline | Sleep as assessed by PROMIS (Patient Reported Outcome Measurement Information System) Sleep Short Form 8B (scale 1-5 where a 5 represents worse sleep) | 4 weeks |
| Change in sleep from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (21 yo and older) living in the USA
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| Name | Affiliation | Role |
|---|---|---|
| Kelsey Laird, PhD | Radicle Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science | Encinitas | California | 92024 | United States |
only aggregated and anonymized data will be shared.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D020447 | Parasomnias |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
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| Arm G | Commercially available, orally ingestible CBD product G |
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| Arm H | Commercially available, orally ingestible CBD product H |
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| Arm I | Commercially available, orally ingestible CBD product I |
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| Arm J | Commercially available, orally ingestible CBD product J |
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| Arm K | Commercially available, orally ingestible CBD product K |
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| Arm L | Commercially available, orally ingestible CBD product L |
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| Arm M | Commercially available, orally ingestible CBD product M |
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| Control | Waitlist control |
Sleep as assessed by PGIC (statement selection much improved to much worse)
| 4 weeks |
| Change in anxiety from baseline | Anxiety as assessed by PGIC (statement selection much improved to much worse) | 4 weeks |
| Less anxiety from baseline | Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety) | 4 weeks |
| Decrease in anxiety from baseline | Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety) | 4 weeks |
| Less pain relative to baseline | Pain as assessed by PEG (scale 1-10 where a higher score is greater pain) | 4 weeks |
| Change in pain from baseline | Pain as assessed by PGIC (statement selection much improved to much worse) | 4 weeks |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |