Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
- Conditions
- Sleep DisturbanceSleepSleep Disorder
- Interventions
- Dietary Supplement: Rest Study Product Usage
- Registration Number
- NCT05511818
- Lead Sponsor
- Radicle Science
- Brief Summary
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2679
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Product 1.1 Rest Study Product Usage Rest Product Form 1 - active product 1 Placebo Control 1 Rest Study Product Usage Rest Product Form 1 - control Placebo Control 2 Rest Study Product Usage Rest Product Form 2 - control Placebo Control 3 Rest Study Product Usage Rest Product Form 3 - control Active Product 1.2 Rest Study Product Usage Rest Product Form 1 - active product 2 Active Product 1.3 Rest Study Product Usage Rest Product Form 1 - active product 3 Active Product 1.4 Rest Study Product Usage Rest Product Form 1 - active product 4 Active Product 4 Rest Study Product Usage Rest Product Form 4 - active product 1 Active Product 3.2 Rest Study Product Usage Rest Product Form 3 - active product 2 Active Product 2.1 Rest Study Product Usage Rest Product Form 2 - active product 1 Active Product 2.2 Rest Study Product Usage Rest Product Form 2 - active product 2 Active Product 3.1 Rest Study Product Usage Rest Product Form 3 - active product 1 Placebo Control 4 Rest Study Product Usage Rest Product Form 4 - control
- Primary Outcome Measures
Name Time Method Change in sleep disturbance 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 Outcome Measures
Name Time Method Change in overall well-being 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)
Change in anxiety 4 weeks Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Change in overall quality of life (QOL) 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)
Change in pain 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)
Change in stress 4 weeks Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)
Change in fatigue 4 weeks Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)
Minimal clinically important difference (MCID) in sleep disturbance 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)
Trial Locations
- Locations (1)
Radicle Science, Inc
🇺🇸Del Mar, California, United States