Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting
- Conditions
- AnxietyPainSleep Disturbance
- Interventions
- Other: Commercially available, orally ingestible CBD product
- Registration Number
- NCT05003882
- Lead Sponsor
- Radicle Science
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm F Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product F Arm D Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product D Arm G Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product G Arm K Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product K Arm C Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product C Arm H Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product H Arm I Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product I Arm L Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product L Arm A Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product A Arm E Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product E Arm B Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product B Arm M Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product M Arm J Commercially available, orally ingestible CBD product Commercially available, orally ingestible CBD product J
- Primary Outcome Measures
Name Time Method 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)
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)
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 Outcome Measures
Name Time Method 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)
Less anxiety from baseline 4 weeks Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety)
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)
Decrease in anxiety from baseline 4 weeks Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety)
Change in anxiety from baseline 4 weeks Anxiety as assessed by PGIC (statement selection much improved to much worse)
Change in pain from baseline 4 weeks Pain as assessed by PGIC (statement selection much improved to much worse)
Trial Locations
- Locations (1)
Radicle Science
🇺🇸Encinitas, California, United States