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

Radicle Science3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Pain Sleep Disturbance Anxiety

Interventions

Commercially available, orally ingestible CBD productOTHER

botanically-derived CBD extract product

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Radicle Science

Encinitas, California, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: 4 weeks

Secondary Outcomes

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)

Time frame: 4 weeks

Change in sleep from baseline

Sleep as assessed by PGIC (statement selection much improved to much worse)

Time frame: 4 weeks

Change in anxiety from baseline

Anxiety as assessed by PGIC (statement selection much improved to much worse)

Time frame: 4 weeks

Less anxiety from baseline

Anxiety as assessed by GAD-7 (scale 0-3 where 3 is greater anxiety)

Time frame: 4 weeks

Decrease in anxiety from baseline

Data from ClinicalTrials.gov

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