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

Pain Clinical Trial

— RWE-ACES  

Official title:

A Randomized, Open-label Study of Commercially Available, Orally Ingestible, Cannabidiol (CBD) Products Used in the Real-world Setting for Pain, Sleep, and Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003882
• Other study ID #: Radicle
• Secondary ID: RADX-2021-002
• Status: Completed
• Start date: August 2, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Dyssomnias
• Pain
• Parasomnias
• Sleep Disturbance

Intervention

Other:
• Commercially available, orally ingestible CBD product
botanically-derived CBD extract product

Locations

Country	Name	City	State
United States	Radicle Science	Encinitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Change in sleep from baseline	Sleep as assessed by PGIC (statement selection much improved to much worse)	4 weeks
Secondary	Change in anxiety from baseline	Anxiety as assessed by PGIC (statement selection much improved to much worse)	4 weeks
Secondary	Less anxiety from baseline	Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety)	4 weeks
Secondary	Decrease in anxiety from baseline	Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety)	4 weeks
Secondary	Less pain relative to baseline	Pain as assessed by PEG (scale 1-10 where a higher score is greater pain)	4 weeks
Secondary	Change in pain from baseline	Pain as assessed by PGIC (statement selection much improved to much worse)	4 weeks