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

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

Detailed Description
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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.

Official Title
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Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

Conditions
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Sleep, Sleep Disturbance, Sleep Disorder

Intervention / Treatment
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* Dietary Supplement: Rest Study Product Usage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1<br>Rest Product Form 1 - control | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Placebo Comparator: Placebo Control 2<br>Rest Product Form 2 - control | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Placebo Comparator: Placebo Control 3<br>Rest Product Form 3 - control | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.1<br>Rest Product Form 1 - active product 1 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.2<br>Rest Product Form 1 - active product 2 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.3<br>Rest Product Form 1 - active product 3 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.4<br>Rest Product Form 1 - active product 4 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 2.1<br>Rest Product Form 2 - active product 1 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 2.2<br>Rest Product Form 2 - active product 2 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 3.1<br>Rest Product Form 3 - active product 1 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 3.2<br>Rest Product Form 3 - active product 2 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Placebo Comparator: Placebo Control 4<br>Rest Product Form 4 - control | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 4<br>Rest Product Form 4 - active product 1 | Dietary Supplement: Rest Study Product Usage<br>* Participants will use their Radicle Rest study product as directed for a period of 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep disturbance | 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall well-being | 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) | 4 weeks | 
| Change in overall quality of life (QOL) | Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL) | 4 weeks | 
| Change in anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 4 weeks | 
| Change in pain | 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) | 4 weeks | 
| Change in stress | Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress) | 4 weeks | 
| Change in fatigue | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue) | 4 weeks | 
| Minimal clinically important difference (MCID) in sleep disturbance | 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) | 4 weeks |