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

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

Detailed Description
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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.

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

Conditions
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Sleep

Intervention / Treatment
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* Dietary Supplement: Sleep 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 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

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 and endorsement of problems with energy and/or focus reported during enrollment, then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Control 1<br>Sleep Product Form 1 - control | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.1<br>Sleep Product Form 1 - active product 1 | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.2<br>Sleep Product Form 1 - active product 2 | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.3<br>Sleep Product Form 1 - active product 3 | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.4<br>Sleep Product Form 1 - active product 4 | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep study product as directed for a period of 4 weeks.<br>|
| Experimental: Active Product 1.5<br>Sleep Product Form 1 - active product 5 | Dietary Supplement: Sleep Study Product Usage<br>* Participants will use their Radicle Sleep 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 | 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]) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quantity | Sleep quantity as assessed by average hours of sleep reported per night | 4 weeks | 
| Change in overall well-being | 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) | 4 weeks | 
| Change in anxiety | 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 weeks | 
| Change in pain | Pain as assessed by Pain on average, Enjoyment of life, and General activity Score (PEG; scale 0-10 where 0 is no pain) | 4 weeks | 
| Achievement of minimum clinically important difference (MCID) in sleep disturbance | Odds of achieving a MCID in sleep disturbance as assessed by Sleep disturbance as assessed by PROMIS Sleep Disturbance SF 8A | 4 weeks |