Anxiety, Pain, Sleep Disturbance
Conditions
Brief summary
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
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.
Interventions
OTHERCommercially available, orally ingestible CBD product
botanically-derived CBD extract product
Sponsors
Radicle Science
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Greater increase in overall well-being from baseline | 4 weeks | Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL) |
| Improvement in overall well-being from baseline | 4 weeks | Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being) |
| Change in overall well-being from baseline | 4 weeks | Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Less anxiety from baseline | 4 weeks | Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety) |
| Decrease in anxiety from baseline | 4 weeks | Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety) |
| Improvement in sleep from baseline | 4 weeks | Sleep as assessed by PROMIS (Patient Reported Outcome Measurement Information System) Sleep Short Form 8B (scale 1-5 where a 5 represents worse sleep) |
| Change in pain from baseline | 4 weeks | Pain as assessed by PGIC (statement selection much improved to much worse) |
| Less pain relative to baseline | 4 weeks | Pain as assessed by PEG (scale 1-10 where a higher score is greater pain) |
| Change in sleep from baseline | 4 weeks | Sleep as assessed by PGIC (statement selection much improved to much worse) |
| Change in anxiety from baseline | 4 weeks | Anxiety as assessed by PGIC (statement selection much improved to much worse) |
Countries
United States
Outcome results
None listed