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Completed

NCT Number: NCT05552898

Radicle Sleep: A Study of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

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Key information

Conditions

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study.

After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 21 years of age and older
  • Resides in the United States
  • Endorses symptoms of sleep disturbance
  • Selects sleep disturbance as a primary reason for taking a cannabinoid product
  • Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
  • Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion criteria

  • Pregnant, trying to become pregnant, or breastfeeding
  • Reports a diagnosis of liver disease
  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
  • Unable to read and understand English
  • Lack of reliable daily access to the internet
  • Reports taking any medication that warns against grapefruit consumption

Treatment and study plan

Sleep Study Product Usage

Dietary Supplement

Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.

Primary outcomes

  1. Change in sleep disturbance

    Time frame: 4 weeks

    Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population [T-score mapping])

Secondary outcomes

  1. Change in sleep quantity

    Time frame: 4 weeks

    Sleep quantity as assessed by average hours of sleep reported per night

  2. Change in overall well-being

    Time frame: 4 weeks

    Change in well-being as assessed by World Health Organization 5 (WHO-5 scale; Scoring from 0 to 25, with higher scores translating to greater well-being)

  3. Change in anxiety

    Time frame: 4 weeks

    Anxiety as assessed by PROMIS Anxiety 4A (Scoring from 4 to 20, with higher scores translating to greater anxiety. Scores are standardized to US general population [T-score mapping)]

  4. Change in pain

    Time frame: 4 weeks

    Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain)

  5. Achievement of minimum clinically important difference (MCID) in sleep disturbance

    Time frame: 4 weeks

    Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 23, 2022
Registry last updated
Nov 22, 2023

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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