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Completed

NCT Number: NCT05003882

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

A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radicle Science

Encinitas, California, 92024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercially available, orally ingestible CBD product

Other

botanically-derived CBD extract product

Primary outcomes

  1. Greater increase in overall well-being from baseline

    Time frame: 4 weeks

    Overall well-being as assessed by KEMP Quality of Life Scale (QOL scale 1-7 where 7 is a better QOL)

  2. Improvement in overall well-being from baseline

    Time frame: 4 weeks

    Overall well-being as assessed by World Health Organization (WHO) 5 Well Being Index (0-5 where 5 is better well-being)

  3. Change in overall well-being from baseline

    Time frame: 4 weeks

    Overall well-being as assessed by Patient Global Impression of Change (PGIC statement selection much improved to much worse)

Secondary outcomes

  1. Improvement in sleep from baseline

    Time frame: 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)

  2. Change in sleep from baseline

    Time frame: 4 weeks

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

  3. Change in anxiety from baseline

    Time frame: 4 weeks

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

  4. Less anxiety from baseline

    Time frame: 4 weeks

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

  5. Decrease in anxiety from baseline

    Time frame: 4 weeks

    Anxiety as assessed by PROMIS Anxiety 4A (scale 1-5 where 5 is greater anxiety)

  6. Less pain relative to baseline

    Time frame: 4 weeks

    Pain as assessed by PEG (scale 1-10 where a higher score is greater pain)

  7. Change in pain from baseline

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study 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

Acronym: RWE-ACES

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2021
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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