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Completed

NCT Number: NCT05511818

Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

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

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Key information

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

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

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 a desire for better sleep
  • Selects sleep 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

Rest Study Product Usage

Dietary Supplement

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

Primary outcomes

  1. Change in sleep disturbance

    Time frame: 4 weeks

    Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)

Secondary outcomes

  1. Change in overall well-being

    Time frame: 4 weeks

    Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)

  2. Change in overall quality of life (QOL)

    Time frame: 4 weeks

    Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)

  3. Change in anxiety

    Time frame: 4 weeks

    Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)

  4. Change in pain

    Time frame: 4 weeks

    Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)

  5. Change in stress

    Time frame: 4 weeks

    Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)

  6. Change in fatigue

    Time frame: 4 weeks

    Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)

  7. Minimal clinically important difference (MCID) in sleep disturbance

    Time frame: 4 weeks

    Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

Radicle™ Rest: A Randomized, Blinded, Placebo-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
2023
First posted
Aug 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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