Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain, Sleep Disturbance, Anxiety

Intervention / Treatment
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* Other: Commercially available, orally ingestible CBD product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 21 years of age Live in the USA Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product Must have regular access to a computer, mobile device, and/or the internet to complete surveys Exclusion Criteria: A person pregnant, trying to become pregnant or breastfeeding Anyone diagnosed with liver disease or considered a heavy drinker Anyone taking medication that warns against grapefruit consumption

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A<br>Commercially available, orally ingestible CBD product A | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm B<br>Commercially available, orally ingestible CBD product B | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm C<br>Commercially available, orally ingestible CBD product C | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm D<br>Commercially available, orally ingestible CBD product D | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm E<br>Commercially available, orally ingestible CBD product E | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm F<br>Commercially available, orally ingestible CBD product F | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm G<br>Commercially available, orally ingestible CBD product G | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm H<br>Commercially available, orally ingestible CBD product H | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm I<br>Commercially available, orally ingestible CBD product I | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm J<br>Commercially available, orally ingestible CBD product J | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm K<br>Commercially available, orally ingestible CBD product K | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm L<br>Commercially available, orally ingestible CBD product L | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Arm M<br>Commercially available, orally ingestible CBD product M | Other: Commercially available, orally ingestible CBD product<br>* botanically-derived CBD extract product<br>|
| Control<br>Waitlist control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |